Ascent Cardiorespiratory Diagnostic Software
FDA 510(k) clearance K242809 · decided 2024-10-17
Clearance details
- K-number
- K242809
- Device name
- Ascent Cardiorespiratory Diagnostic Software
- Applicant
- Medical Graphics Corporation
- Decision
- Substantially Equivalent
- Date received
- 2024-09-17
- Decision date
- 2024-10-17
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- BTY
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Paul, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SpiroSphere, SpiroSphereECG, CardioSphere (K223629) | Eresearchtechnology GmbH | 2024-05-28 |
| Pulmonary Function Tester, Model: A9 (K231561) | Guangzhou Homesun Medical Technology Co., Ltd. | 2024-02-21 |
| Virtus Metabolic Monitor (K222982) | Virtus Technology Aps | 2023-06-23 |
| Model 9100 PFT/DICO (K221030) | Vitalograph Ireland, Ltd. | 2022-07-15 |
| MasterScope, MasterScope CT, MasterScope ECG, MasterScope WSSU (K202754) | Eresearchtechnology GmbH | 2021-01-28 |
| Cosmed Q-NRG / Q-NRG+ Portable Metabolic Monitors (K190800) | Cosmed Srl | 2020-02-06 |
| Ascent Cardiorespiratory Diagnostic Software (K181912) | Medical Graphics Corporation | 2019-04-12 |
| SpiroSphere (K173937) | Eresearchtechnology GmbH | 2019-02-15 |
| EasyOne Pro Respiratory Analysis System (K161534) | Ndd Medizintechnik AG | 2017-02-22 |
| Shape-HF Cardiopulmonary Testing System (K150888) | Shape Medical Systems, Inc. | 2016-01-21 |
| SENTRYSUITE PRODUCT LINE (K122699) | Carefusion Germany 234 GmbH | 2012-11-19 |
| EASYONE PRO RESPIRATORY TESTING DEVICE (K120635) | Ndd Medizitechnik AG | 2012-09-27 |
Recalls involving this device
No recalls on record reference this clearance.