Shape Medical Systems, Inc
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 2
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1060-2015 | Class II | Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001. | December 23, 2014 |
| Z-2051-2014 | Class II | Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable | May 28, 2014 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K150888 | Shape-HF Cardiopulmonary Testing System | January 21, 2016 |
| K090722 | SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM | March 31, 2009 |