Cleared Traditional

SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1

K180098 · Maquet Critical Care AB · Anesthesiology
Mar 2019
Decision
427d
Days
Class 2
Risk

About This 510(k) Submission

K180098 is an FDA 510(k) clearance for the SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1, 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 March 19, 2019, 427 days after receiving the submission on January 16, 2018. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5895.

Submission Details

510(k) Number K180098 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2018
Decision Date March 19, 2019
Days to Decision 427 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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