510(k) K150888 ยท BTY Calculator, Predicted Values, Pulmonary Function
Shape-HF Cardiopulmonary Testing System
| Applicant | Shape Medical Systems, Inc., St. Paul MN, US |
| Decision | Substantially Equivalent, Jan 21, 2016 |
| Received | Apr 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150888
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.