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 IDK110213
510k NumberK110213
Device Name:GE DATEX-OHMEDA AISYS
ClassificationGas-machine, Anesthesia
Applicant DATEX-OHMEDA, INC. PO BOX 7550 3030 OHMEDA DR. Madison,  WI  53707 -7550
ContactJim Raskob
CorrespondentJim Raskob
DATEX-OHMEDA, INC. PO BOX 7550 3030 OHMEDA DR. Madison,  WI  53707 -7550
Product CodeBSZ  
CFR Regulation Number868.5160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-01-25
Decision Date2011-07-20
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.