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

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, Flow-c Anesthesia System, Flow-e Anesthesia System.

Pre-market Notification Details

Device IDK191027
510k NumberK191027
Device Name:Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
ClassificationGas-machine, Anesthesia
Applicant Maquet Critical Care AB Rontgenvagen 2 Solna,  SE 17154
ContactKribu Valdre
CorrespondentMark N. Smith
Getinge 45 Barbour Pond Drive Wayne,  NJ  07470
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyAnesthesiology
510k Review PanelAnesthesiology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-04-18
Decision Date2020-03-18

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