Cleared Traditional

ALLEGIANCE PORTA-WARM MATTRESS

K982652 · Allegiance Healthcare Corp. · Physical Medicine
Jan 1999
Decision
175d
Days
Class 1
Risk

About This 510(k) Submission

K982652 is an FDA 510(k) clearance for the ALLEGIANCE PORTA-WARM MATTRESS, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on January 21, 1999, 175 days after receiving the submission on July 30, 1998. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number K982652 FDA.gov
FDA Decision Cleared SESE
Date Received July 30, 1998
Decision Date January 21, 1999
Days to Decision 175 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF

Device Classification

Product Code IMD — Pack, Hot Or Cold, Disposable
Device Class Class I — General Controls
CFR Regulation 21 CFR 890.5710

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