Cleared Traditional

Babyroo TN300

K230278 · Draeger Medical Systems, Inc. · General Hospital
May 2023
Decision
118d
Days
Class 2
Risk

About This 510(k) Submission

K230278 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 May 30, 2023, 118 days after receiving the submission on February 1, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5130.

Submission Details

510(k) Number K230278 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2023
Decision Date May 30, 2023
Days to Decision 118 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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