510(k) K913291 ยท FMZ Incubator, Neonatal
MODEL C386 ISOLETTE(R) INFANT INCUBATOR
| Applicant | Air-Shields, Inc., Hatboro PA, US |
| Decision | Substantially Equivalent, Nov 13, 1991 |
| Received | Jul 24, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913291
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.