510(k) K090438 ยท DQA Oximeter
REUSABLE ENVITEC FINGER SPO2 SENSOR-HP/PHILIPS COMPATIBLE, MODELS F-2412, F-2414-15, REUSABLE ENVITEC EAR SPO2 SENSOR
| Applicant | Envitec-Wismar GmbH, Egale WI, US |
| Decision | Substantially Equivalent, Jul 24, 2009 |
| Received | Feb 20, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090438
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.