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

Gas-machine, Anesthesia

MAQUET CRITICAL CARE AB

The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Flow-i Anesthesia System C20, Flow-i Anesthesia System C30, Flow-i Anesthesia System C40.

Pre-market Notification Details

Device IDK160665
510k NumberK160665
Device Name:FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia System C40
ClassificationGas-machine, Anesthesia
Applicant MAQUET CRITICAL CARE AB RONTGENVAGEN 2 Solna,  SE Se-171 54
ContactCarina Lundberg
CorrespondentMark Dinger
MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE Wayne,  NJ  07470
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-09
Decision Date2017-03-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07325710009604 K160665 000

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