510(k) K813352 ยท KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
NOVAMETRIX MODEL 816A TRANSCUT. OXYGEN
| Applicant | Novametrix Medical Systems, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Jan 7, 1982 |
| Received | Nov 27, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813352
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.