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FDA 510(k)

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40

K-Number: K160665 · 2017-03-29

ApplicantMaquet Critical Care AB
Decision Date2017-03-29
Product CodeBSZ
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is a medical device manufactured by Maquet Critical Care AB. It received FDA 510(k) clearance on 2017-03-29 under approval number K160665. 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 C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is a medical device that received FDA 510(k) clearance on 2017-03-29. It is manufactured by Maquet Critical Care AB. The 510(k) number is K160665.

When was FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 approved by the FDA?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 received FDA 510(k) clearance on 2017-03-29, under approval number K160665.

What company makes FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is manufactured by Maquet Critical Care AB.

What is the FDA product code for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40?

The FDA product code for FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40 is BSZ.

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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. K171311A5 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K171292A7 Anesthesia SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. K191027Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia SystemMaquet Critical Care AB

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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