Electrocardiograph, model: ECG301
FDA 510(k) clearance K232816 · decided 2024-06-07
Clearance details
- K-number
- K232816
- Device name
- Electrocardiograph, model: ECG301
- Applicant
- Shenzhen LE Medical Technology Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2023-09-13
- Decision date
- 2024-06-07
- Days to decision
- 268 days
- Clearance type
- Traditional
- Product code
- DPS
- Device class
- 2
- Regulation number
- 870.2340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Shenzhen, CN
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
| SE-1202 Series Electrocardiograph (Model: SE-1202, SE-1202E) (K252463) | Edan Instruments, Inc. | 2026-07-02 |
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| 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 |
Recalls involving this device
No recalls on record reference this clearance.