510(k) K941106 ยท FPL Incubator, Neonatal Transport
MODEL TI500 ISOLETTE INFANT INCUBATOR
| Applicant | Air-Shields, Inc., Hatboro PA, US |
| Decision | Substantially Equivalent, Jun 10, 1994 |
| Received | Mar 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K941106
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2008 | Draeger Medical, Inc. Draeger TI500. Isolette Infant Incubator. Catalog Number: MU20505. Draeger Medical, Inc., Telford, PA 18969 Terminated |
FMZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.