Submission Details
| 510(k) Number | K040856 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 02, 2004 |
| Decision Date | May 03, 2004 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | Summary PDF |
Cleared
Traditional
RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER
May 2004
Decision
31d
Days
Class 1
Risk
About This 510(k) Submission
K040856 is an FDA 510(k) clearance for the RAPID AID INSTANT DISPOSABLE INFANT HEEL WARMER, a Infant Heel Warmer (chemical Heat Pack) (Class I — General Controls, product code MPO), submitted by Rapid Aid , Ltd. (Mississauga, Ontario, CA). The FDA issued a Cleared decision on May 3, 2004, 31 days after receiving the submission on April 2, 2004. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.
Device Classification
| Product Code | MPO — Infant Heel Warmer (chemical Heat Pack) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 890.5710 |
Manufacturer
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