510(k) K813214 ยท FOK Pad, Neonatal Eye
INFANT PHOTOTHERAPY MASK
| Applicant | Montrose Phototherapy Supply, Walker MI, US |
| Decision | Substantially Equivalent, Dec 9, 1981 |
| Received | Nov 9, 1981 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K813214
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.