SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION

Ventilator, Continuous, Facility Use

MAQUET CRITICAL CARE AB

The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo-i Ventilator System, Model 64 87 800 E407e; Nava Option.

Pre-market Notification Details

Device IDK062793
510k NumberK062793
Device Name:SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E; NAVA OPTION
ClassificationVentilator, Continuous, Facility Use
Applicant MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 Bridgewater,  NJ  08807
ContactJamie Yieh
CorrespondentJamie Yieh
MAQUET CRITICAL CARE AB 1140 ROUTE 22 EAST SUITE 202 Bridgewater,  NJ  08807
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-09-18
Decision Date2007-02-07
Summary:summary

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