| SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (K252463) | Edan Instruments, Inc. | 2026-07-02 |
| MAC 7 Resting ECG Analysis System (K251670) | Ge Medical Systems Information Technologies, Inc. | 2026-01-26 |
| AccurECG Analysis System (v2.0) (K252361) | Accurkardia, Inc. | 2025-12-22 |
| Withings BeamO (SCT02) (K252474) | Withings | 2025-11-10 |
| Cardiologs Holter Platform (K250569) | Philips France Commercial | 2025-08-06 |
| ZBPro Diagnostic (K243252) | Zbeats, Inc. | 2025-07-10 |
| Masimo W1 (K243305) | Masimo Corporation | 2025-04-03 |
| CloudHRV™ System (100-01-001) (K241217) | Inmedix, Inc. | 2025-01-16 |
| Cardiac Workstation (5000); Cardiac Workstation (7000) (K241556) | Philips Medizin Systeme Böblingen GmbH | 2024-12-17 |
| Masimo W1 (K240229) | Masimo Corporation | 2024-08-08 |
| DeepRhythm Platform (K232161) | Medicalgorithmics S.A. | 2024-06-20 |
| MEDIBLU ECG SYSTEM (K233266) | Mediblu Medical, LLC | 2024-06-12 |
| Impala (K232035) | AliveCor, Inc. | 2024-06-07 |
| Electrocardiograph, model: ECG301 (K232816) | Shenzhen LE Medical Technology Co., Ltd. | 2024-06-07 |
| CSF-4 (CSF-4) (K232445) | Cardiacsense | 2024-05-02 |
| MCG-S (AM1000) (K232823) | Amcg Co., Ltd. | 2024-04-05 |
| Cardio Q50, Cardio Q70 (K231160) | Bionet Co., Ltd. | 2023-12-15 |
| CARDIPIA ECG / Model: CARDIPIA400H, CARDIPIA800H (K230834) | Trismed Co., Ltd. | 2023-11-21 |
| Masimo W1 (K232512) | Masimo Corporation | 2023-11-17 |
| EKGenius Smart System (K232974) | Ekgenius, LLC | 2023-11-17 |
| Cardio P1 (K231150) | Bionet Co., Ltd. | 2023-11-09 |
| Withings Scan Monitor 2.0 (K230812) | Withings | 2023-08-23 |
| MESI mTablet ECG Diagnostic System, MESI mTablet ECG (K223670) | Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. | 2023-07-28 |
| Electrocardiograph: SE-1200 Pro and SE-1201 Pro (K222902) | Edan Instruments, Inc. | 2023-07-28 |
| AccurECG Analysis System (K223013) | Accurkardia, Inc. | 2023-06-23 |
| CSF-3 (K221260) | Cardiacsense | 2023-01-06 |
| PageWriter TC35 Cardiograph (K221141) | Medizin Systeme Boblingen GmbH | 2022-12-02 |
| Cardio10 (K220535) | Bionet Co., Ltd. | 2022-11-15 |
| MAC 5 A4/ MAC 5 A5/ MAC 5 Lite Resting ECG Analysis System (K221321) | Ge Medical Systems Information Technologies, Inc. | 2022-10-18 |
| Coala Heart Monitor (K212163) | Coala Life AB | 2022-04-14 |
| Electrocardiograph (K212278) | Edan Instruments, Inc. | 2022-04-07 |
| LE-12CH (K220362) | Caf Medical Solutions, Inc. | 2022-03-25 |
| Cardiologs Holter Platform (K212112) | Cardiologs Technologies | 2021-11-18 |
| Scan Monitor (K201456) | Withings SA | 2021-10-05 |
| electrocardiograph: SE-1202 (K210140) | Edan Instruments, Inc. | 2021-10-01 |
| Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph (K210560) | Philips Medical Systems | 2021-06-30 |
| MAC 7 - Resting ECG Analysis System (K203786) | Ge Medical Systems Information Technologies, Inc. | 2021-04-30 |
| B-Secur HeartKey Software Library (K200884) | B-Secur , Ltd. | 2020-12-07 |
| PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph (K191738) | Philips Medical Systems | 2020-09-29 |
| physIQ Heart Rhythm and Respiration Module (K193415) | Physiq, Inc. | 2020-06-11 |
| AI-ECG Tracker (K200036) | Shenzhen Carewell Electronics Co., Ltd. | 2020-03-20 |
| CARDIOVIT AT-102 G2 (K183425) | Schiller AG | 2020-03-02 |
| KardioScreen (K191692) | Imedrix Inc. (Formerly Piitech Inc.) | 2020-01-10 |
| physIQ Heart Rhythm and Respiratory Module (K183322) | Physiq, Inc. | 2019-07-10 |
| CardioFlux with Faraday Analytical Cloud (K182571) | Genetesis, Inc. | 2019-03-15 |
| ZOLL ECG Analysis Software (K182093) | Zoll Manufacturing Corporation | 2019-01-28 |
| COR12 ECG (K183369) | Corscience GmbH & Co. | 2018-12-28 |
| Cardio-TriTest v6.5 (K182790) | Cardio-Phoenix, Inc. | 2018-12-14 |
| CardioBand ECG Event Recorder (K181998) | Samsung Strategy and Innovation Center (Ssic) | 2018-11-15 |
| MAC VU360 Resting ECG Analysis System (K173830) | Ge Medical Systems Information Technologies, Inc. | 2018-09-18 |
| Universal SmartECG (K173952) | Vectracor, Inc. | 2018-08-28 |
| physiQ Heart Rhythm Module (K180234) | Physiq, Inc. | 2018-08-10 |
| CheckMyHeart Plus (K172778) | Dailycare Biomedical, Inc. | 2018-07-05 |
| Kenz Cardico1211 (K172068) | Suzuken Co., Ltd. | 2018-06-01 |
| CardiMax Electrocardiograph (K173226) | Fukuda Denshi USA, Inc. | 2018-04-16 |
| HeRO Symphony, HeRO ES, HeRO solo/duet (K180242) | Medical Predictive Science Corporation | 2018-02-28 |
| MiCor A100 Wearable ECG Recorder (K162665) | Mitac International Corp. | 2018-01-26 |
| Electrocardiograph (K171942) | Edan Instruments, Inc. | 2018-01-24 |
| CONTEC™ Electrocardiograph (K171360) | Contec Medical Systems Co.,Ltd | 2018-01-22 |
| Digital Electrocardiograph (K171517) | Biocare Bio-Medical Equipment Co., Ltd. | 2018-01-11 |
| ECG Acquisition Systems (K163607) | Vales & Hills Biomedical Tech. , Ltd. | 2017-12-15 |
| Creavo Vitalscan Magnetocardiograph (K170154) | Creavo Medical Technologies, Ltd. | 2017-10-12 |
| Electrocardiograph (K171943) | Edan Instruments, Inc. | 2017-09-25 |
| CARDIOVIT FT-1 (K170182) | Schiller AG | 2017-07-19 |
| CardioLogs ECG Analysis Platform (K170568) | Cardiologs Technologies | 2017-06-26 |
| Electrocardiograph (K170995) | Edan Instruments, Inc. | 2017-06-02 |
| Portable ECG Monitor (K170954) | Contec Medical Systems Co.,Ltd | 2017-05-30 |
| Anybattery C2 Rechargeable Battery (K160667) | Anybattery, Inc. | 2017-05-11 |
| PC ECG (K160876) | Edan Instruments, Inc. | 2017-02-15 |
| CARDIOLINE touchECG (K160746) | Cardioline S.P.A | 2016-11-02 |
| ECG100+, ECG200+ (K160840) | Cardioline S.P.A | 2016-08-12 |
| Quantitative Electrocardiographic Detector (QED 2000) (K152135) | Acme Portable Machines, Inc. | 2016-08-09 |
| PC ECG (K161302) | Edan Instruments, Inc. | 2016-07-01 |
| Portable ECG Monitor (K152863) | Contec Medical Systems Co.,Ltd | 2016-06-22 |
| Diagnostic Station DS20 (K152043) | Schiller AG | 2016-05-06 |
| MODEL 621/624 BIOMAGNETOMETER (K151135) | Tristan Technologies, Inc. | 2016-03-15 |
| ANI Monitor (K142969) | Mdoloris Medical Systems Sas | 2016-02-23 |
| Digital Electrocardiograph (K160092) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2016-02-12 |
| PC ECG (K152427) | Edan Instruments, Inc. | 2016-02-05 |
| Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems (K152944) | Mortara Instrument, Inc. | 2016-01-06 |
| Digital Electrocardiograph (K152384) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-12-18 |
| Spaulding Electrocardiograph 2100iQ (K150564) | Spaulding Clinical Research, LLC | 2015-08-12 |
| Cardio-TriTest (K143432) | Cardio-Phoenix, Inc. | 2015-06-03 |
| InvisionECG System (K143436) | Invisionheart, Inc. | 2015-05-21 |
| QANS (Quantitative Autonomic Nervous System) Monitoring System (K142551) | Hhssystems, LLC | 2015-04-16 |
| ZywieAI Software Library (K142693) | Zywie, Inc. | 2015-02-20 |
| DIGITAL ELECTROCARDIOGRAPH (K141946) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-02-13 |
| DIGITAL ELECTROCARDIOGRAPH (K133985) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2015-01-22 |
| MAC 800 Resting ECG Analysis System (K142288) | Ge Medical Systems China Co., Ltd. | 2014-12-03 |
| HYPERQ ACS-100 SYSTEM (K140020) | Bsp-Biiological Signal Processing, Ltd. | 2014-10-28 |
| ELI 380 ELECTROCARDIOGRAPH (K142105) | Mortara Instrument, Inc. | 2014-09-05 |
| CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION (K141582) | Welch Allyn | 2014-07-11 |
| DIGITAL ELECTROCARDIOGRAPH (K131858) | Guangdong Biolight Meditech Co., Ltd. | 2014-06-11 |
| CONTEC ELECTROCARDIOGRAPH (K131900) | Contec Medical System Co., Ltd. | 2014-03-05 |
| SE-601 SERIES ELECTROCARDIOGRAPH (K131503) | Edan Instruments, Inc. | 2014-02-25 |
| GUAVA II (K122632) | Cardiocomm Solutions, Inc. | 2014-02-11 |
| ALIVECOR HEART MONITOR OTC (K130921) | AliveCor, Inc. | 2014-02-06 |
| DIGITAL ELECTROCARDIOGRAPH (K132758) | Shenzhen Biocare Bio-Medical Equipment Co., Ltd. | 2014-01-30 |
| MAC 2000 ECG ANALYSIS SYSTEM (K133622) | Wipro GE Healthcare | 2014-01-23 |
| PC ECG (K131819) | Edan Instruments, Inc. | 2013-11-22 |