510(k) K861861 ยท KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
515A NEO-TRAK NEONATAL MONITOR
| Applicant | Ge Medical Systems Information Technologies, Wallingford CT, US |
| Decision | Substantially Equivalent, Jul 10, 1986 |
| Received | May 14, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861861
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.