510(k) K934631 ยท IMD Pack, Hot Or Cold, Disposable
TRANSWARMER
| Applicant | Prism Technologies, Inc., San Antonio TX, US |
| Decision | Substantially Equivalent, Feb 3, 1994 |
| Received | Sep 24, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934631
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2019 | CooperSurgical, Inc. TransWarmer Warming Infant Transport Mattress, Model no. 20421
Product Usage:
The TransWarmer Warming Infant Transport Mattress is gel-filled, disposable mattress that provides heat for up to two ho Terminated |
IMD | None listed |
| Apr 7, 2015 | CooperSurgical, Inc. CooperSurgical TransWarmer Infant Transport Mattress with WarmGel
P/N 20421
Private label:
NovaPlus TransWarmer Infant Heat Therapy Mattress with
WarmGel. P/N V6390
Provides warmth during transport o Terminated |
IMD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.