510(k) K830197 ยท KLK Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
TRANSCUTANEOUS BLOOD OXYGEN SENSOR SYS
| Applicant | Diamond Shamrock Corp., Walker MI, US |
| Decision | Substantially Equivalent, Nov 29, 1983 |
| Received | Jan 20, 1983 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K830197
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.