Servo-air 4.0 Ventilator System

Ventilator, Continuous, Facility Use

Maquet Critica Care AB

The following data is part of a premarket notification filed by Maquet Critica Care Ab with the FDA for Servo-air 4.0 Ventilator System.

Pre-market Notification Details

Device IDK192604
510k NumberK192604
Device Name:Servo-air 4.0 Ventilator System
ClassificationVentilator, Continuous, Facility Use
Applicant Maquet Critica Care AB Röntgenvägen 2 Solna,  SE 17154
ContactDavid Ardanius
CorrespondentMark N. Smith
Getinge 45 Barbour Pond Drive Wayne,  NJ  07470
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-20
Decision Date2020-06-18

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