GE DATEX-OHMEDA AISYS

Gas-machine, Anesthesia

DATEX-OHMEDA, INC.

The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Ge Datex-ohmeda Aisys.

Pre-market Notification Details

Device IDK073707
510k NumberK073707
Device Name:GE DATEX-OHMEDA AISYS
ClassificationGas-machine, Anesthesia
Applicant DATEX-OHMEDA, INC. PO BOX 7550 Madison,  WI  53707
ContactDan Kosednar
CorrespondentDan Kosednar
DATEX-OHMEDA, INC. PO BOX 7550 Madison,  WI  53707
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-12-31
Decision Date2008-01-30

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