GE DATEX-OHMEDA ENGSTROM CARESTATION

Ventilator, Continuous, Facility Use

DATEX-OHMEDA, INC.

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

Pre-market Notification Details

Device IDK051895
510k NumberK051895
Device Name:GE DATEX-OHMEDA ENGSTROM CARESTATION
ClassificationVentilator, Continuous, Facility Use
Applicant DATEX-OHMEDA, INC. PO BOX 7550 Madison,  WI  53707
ContactDan Kosednar
CorrespondentDan Kosednar
DATEX-OHMEDA, INC. PO BOX 7550 Madison,  WI  53707
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-13
Decision Date2005-09-27
Summary:summary

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