510(k) K800631 ยท KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
OXYMETER
| Applicant | Dragerwerk AG, Mchenry IL, US |
| Decision | Substantially Equivalent, Apr 2, 1980 |
| Received | Mar 20, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K800631
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.