510(k) K082655 ยท CCL Analyzer, Gas, Oxygen, Gaseous-Phase
ENVITEC MEDICAL OXYGEN SENORS, MODELS OOM101; 00M102/-1;OOM103/-1/-1M;OOM104;OOM105;00M106
| Applicant | Envitec-Wismar GmbH, Egale WI, US |
| Decision | Substantially Equivalent, Nov 25, 2008 |
| Received | Sep 12, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082655
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.