K961154 is an FDA 510(k) clearance for the BAXTER SODIUM ACETATE INFANT HEEL WARMER. This device is classified as a Infant Heel Warmer (chemical Heat Pack) (Class I - General Controls, product code MPO).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on June 6, 1996, 76 days after receiving the submission on March 22, 1996.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K961154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 22, 1996 |
| Decision Date | June 06, 1996 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
| Product Code | MPO — Infant Heel Warmer (chemical Heat Pack) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |