Cleared Traditional

Evita V800, Evita V600

K222024 · Draegerwerk AG & CO Kgaa · Anesthesiology
May 2023
Decision
309d
Days
Class 2
Risk

About This 510(k) Submission

K222024 is an FDA 510(k) clearance for the Evita V800, Evita V600, 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, 309 days after receiving the submission on July 11, 2022. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K222024 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2022
Decision Date May 16, 2023
Days to Decision 309 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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