K950680 is an FDA 510(k) clearance for the INFANT HEEL WARMER. This device is classified as a Pack, Hot Or Cold, Disposable (Class I - General Controls, product code IMD).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on August 23, 1995, 190 days after receiving the submission on February 14, 1995.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K950680 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - NSE Converted (SN) |
| Date Received | February 14, 1995 |
| Decision Date | August 23, 1995 |
| Days to Decision | 190 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | IMD — Pack, Hot Or Cold, Disposable |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 890.5710 |