Cleared Traditional

Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1

K201874 · Maquet Critical Care AB · Anesthesiology
Apr 2021
Decision
287d
Days
Class 2
Risk

About This 510(k) Submission

K201874 is an FDA 510(k) clearance for the Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1, a Ventilator, Continuous, Facility Use (Class II — Special Controls, product code CBK), submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on April 20, 2021, 287 days after receiving the submission on July 7, 2020. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K201874 FDA.gov
FDA Decision Cleared SESE
Date Received July 07, 2020
Decision Date April 20, 2021
Days to Decision 287 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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