510(k) K120642 ยท FMT Warmer, Infant Radiant
RESUSCITAIRE WITH AUTOBREATH
| Applicant | Draeger Medical Systems, Inc., Telford PA, US |
| Decision | Substantially Equivalent, Nov 2, 2012 |
| Received | Mar 2, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K120642
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2023 | Draeger Medical Systems, Inc. Draeger Softbed Resuscitaire and/or Birthing Room Warmer with Scale [Model(s): RW82VHA-1, RW82VHA-1C, RW82VHA-1D, RW82-1, RW82-1C, RW82-1D, WBR82-1 and WBR82-1C] Open, Classified |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.