Cleared Traditional

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System

K191027 · Maquet Critical Care AB · Anesthesiology
Mar 2020
Decision
335d
Days
Class 2
Risk

About This 510(k) Submission

K191027 is an FDA 510(k) clearance for the Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System, a Gas-machine, Anesthesia (Class II — Special Controls, product code BSZ), submitted by Maquet Critical Care AB (Solna, SE). The FDA issued a Cleared decision on March 18, 2020, 335 days after receiving the submission on April 18, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5160.

Submission Details

510(k) Number K191027 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 2019
Decision Date March 18, 2020
Days to Decision 335 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code BSZ — Gas-machine, Anesthesia
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5160

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