510(k) K971198 ยท FMT Warmer, Infant Radiant
BABYTHERM 8004 BABYTHERM 8010
| Applicant | Drager, Inc., Chantilly VA, US |
| Decision | Substantially Equivalent, Oct 3, 1997 |
| Received | Mar 31, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971198
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 22, 2016 | Draeger Medical, Inc. Babytherm 8004/8010, Infant Warmer, Class II device, 510 K K971198, Catalog # FR00105 (Babytherm 8010), 2M30404 (Babytherm 8004), non sterile, software controlled.
Product Usage:
Babytherm 8004/8010 Terminated |
FMT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.