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FDA 510(k)

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

K-Number: K191027 · 2020-03-18

ApplicantMaquet Critical Care AB
Decision Date2020-03-18
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System is a medical device manufactured by Maquet Critical Care AB. It received FDA 510(k) clearance on 2020-03-18 under approval number K191027. The device is classified under product code BSZ. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System?

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Maquet Critical Care AB. The 510(k) number is K191027.

When was Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System approved by the FDA?

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System received FDA 510(k) clearance on 2020-03-18, under approval number K191027.

What company makes Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System?

Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System is manufactured by Maquet Critical Care AB.

What is the FDA product code for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System?

The FDA product code for Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System is BSZ.

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Other Devices by Maquet Critical Care AB

K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 K153688Edi Catheter ENFit K182862Servo Guard K180098SERVO-U Ventilator System version 2.1; SERVO-n Ventilator System version 2.1 K201874Servo-u Ventilator System 4.1, Servo-n Ventilator System 4.1, Servo-u MR Ventilator System 4.1 K230173Servo-air Lite Ventilator System

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Related Devices (Code: BSZ)

K151570Carestation 620/650/650CDatex-Ohmeda, Inc. K172045Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2Datex-Ohmeda, Inc. K170872Aisys CS2Datex-Ohmeda, Inc. K160665FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40Maquet Critical Care AB K171311A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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