DRAGER MICRO VENT

Ventilator, Continuous, Facility Use

DRAGER, INC.

The following data is part of a premarket notification filed by Drager, Inc. with the FDA for Drager Micro Vent.

Pre-market Notification Details

Device IDK953238
510k NumberK953238
Device Name:DRAGER MICRO VENT
ClassificationVentilator, Continuous, Facility Use
Applicant DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly,  VA  22021
ContactHarald Kneuer
CorrespondentHarald Kneuer
DRAGER, INC. 4101-100 PLEASANT VALLEY RD. Chantilly,  VA  22021
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSe Subject To Tracking Reg (ST)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-07-11
Decision Date1996-09-16

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