K040044 is an FDA 510(k) clearance for the HEEL SNUGGLER, MODEL 99047. This device is classified as a Infant Heel Warmer (chemical Heat Pack) (Class I - General Controls, product code MPO).
Submitted by Respironics, Inc. (Murrysville, US). The FDA issued a Cleared decision on January 27, 2004, 15 days after receiving the submission on January 12, 2004.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5710.
| 510(k) Number | K040044 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 12, 2004 |
| Decision Date | January 27, 2004 |
| Days to Decision | 15 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 |