Cleared Traditional

Panda iRes Warmer, Giraffe Warmer

K201628 · Ge Healthcare · General Hospital
Feb 2021
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K201628 is an FDA 510(k) clearance for the Panda iRes Warmer, Giraffe Warmer, a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on February 12, 2021, 241 days after receiving the submission on June 16, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K201628 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2020
Decision Date February 12, 2021
Days to Decision 241 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FMT — Warmer, Infant Radiant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5130

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