Cleared Traditional

Babylog VN800, Babylog VN600

K222207 · Draegerwerk AG & CO Kgaa · Anesthesiology
May 2023
Decision
295d
Days
Class 2
Risk

About This 510(k) Submission

K222207 is an FDA 510(k) clearance for the Babylog VN800, Babylog VN600, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Draegerwerk AG & CO Kgaa (Luebeck, DE). The FDA issued a Cleared decision on May 16, 2023, 295 days after receiving the submission on July 25, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K222207 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2022
Decision Date May 16, 2023
Days to Decision 295 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code CBK — Ventilator, Continuous, Facility Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5895

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