510(k) K090722 ยท BTY Calculator, Predicted Values, Pulmonary Function
SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM
| Applicant | Shape Medical Systems, Inc., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 31, 2009 |
| Received | Mar 19, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090722
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 5, 2015 | Shape Medical Systems, Inc Shape-HF Cardiopulmonary Testing System Disposable Patient Interface (DPI). Part Number 0004-4001.
The Shape-HF Cardiopulmonary Exercise Testing System is a stationary device that monitors paramet Terminated |
BTY | None listed |
| Jul 14, 2014 | Shape Medical Systems, Inc Shape HF Cardiopulmonary System. Made up of Shape HF System Analyzer (PN 0001-9001) and Disposable Patient Interface (DPI), (PN 0004-4001). A pulmonary gas exchange testing system used during cardi Terminated |
BTY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.