NARKOMED 6400, MODEL NM6400

Gas-machine, Anesthesia

DRAEGER MEDICAL, INC.

The following data is part of a premarket notification filed by Draeger Medical, Inc. with the FDA for Narkomed 6400, Model Nm6400.

Pre-market Notification Details

Device IDK033498
510k NumberK033498
Device Name:NARKOMED 6400, MODEL NM6400
ClassificationGas-machine, Anesthesia
Applicant DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford,  PA  18969
ContactGale E Winarsky
CorrespondentGale E Winarsky
DRAEGER MEDICAL, INC. 3135 QUARRY RD. Telford,  PA  18969
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-11-05
Decision Date2004-04-26
Summary:summary

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