Cleared Traditional

Babyroo TN300

K243606 · Draeger Medical Systems, Inc. · General Hospital
Jan 2025
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K243606 is an FDA 510(k) clearance for the Babyroo TN300, a Warmer, Infant Radiant (Class II — Special Controls, product code FMT), submitted by Draeger Medical Systems, Inc. (Telford, US). The FDA issued a Cleared decision on January 17, 2025, 57 days after receiving the submission on November 21, 2024. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K243606 FDA.gov
FDA Decision Cleared SESE
Date Received November 21, 2024
Decision Date January 17, 2025
Days to Decision 57 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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