ENGSTROM CARESTATION, ENGSTROM PRO

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 Engstrom Carestation, Engstrom Pro.

Pre-market Notification Details

Device IDK081842
510k NumberK081842
Device Name:ENGSTROM CARESTATION, ENGSTROM PRO
ClassificationVentilator, Continuous, Facility Use
Applicant DATEX-OHMEDA, INC. P.O. BOX 7550 Madison,  WI  53707
ContactAdrienne Lenz
CorrespondentAdrienne Lenz
DATEX-OHMEDA, INC. P.O. BOX 7550 Madison,  WI  53707
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-30
Decision Date2008-10-03
Summary:summary

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