SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
FDA 510(k) clearance K090722 · decided 2009-03-31
Clearance details
- K-number
- K090722
- Device name
- SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
- Applicant
- Shape Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-03-19
- Decision date
- 2009-03-31
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- BTY
- Device class
- 2
- Regulation number
- 868.1890
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Minneapolis, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 00 recall (Z-1060-2015) | Shape Medical Systems, Inc | 2015-02-05 |
| Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Di recall (Z-2051-2014) | Shape Medical Systems, Inc | 2014-07-14 |