Cleared Traditional

HEEL SNUGGLER, MODEL 99047

K040044 · Respironics, Inc. · Physical Medicine
Jan 2004
Decision
15d
Days
Class 1
Risk

About This 510(k) Submission

K040044 is an FDA 510(k) clearance for the HEEL SNUGGLER, MODEL 99047, 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 review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number K040044 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code MPO — Infant Heel Warmer (chemical Heat Pack)
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5710

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