Cleared Traditional

Infant Transport Mattress Warmer with Disc

K163295 · Rapid Aid Corp. · Physical Medicine

Jul 2017

Decision

244d

Days

Class 1

Risk

About This 510(k) Submission

K163295 is an FDA 510(k) clearance for the Infant Transport Mattress Warmer with Disc, a Pack, Hot Or Cold, Disposable (Class I — General Controls, product code IMD), submitted by Rapid Aid Corp. (Mississauga, CA). The FDA issued a Cleared decision on July 24, 2017, 244 days after receiving the submission on November 22, 2016. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.5710.

Submission Details

510(k) Number	K163295 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 22, 2016
Decision Date	July 24, 2017
Days to Decision	244 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Summary PDF