510(k) K961154 ยท MPO Infant Heel Warmer (Chemical Heat Pack)
BAXTER SODIUM ACETATE INFANT HEEL WARMER
| Applicant | Baxter Healthcare Corp, Mcgaw Park IL, US |
| Decision | Substantially Equivalent, Jun 6, 1996 |
| Received | Mar 22, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 17, 2023 | Cardinal Health 200, LLC NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010 Open, Classified |
MPO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.