ENGSTROM CARESTATION, ENGSTROM PRO

Ventilator, Continuous, Facility Use

DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C

The following data is part of a premarket notification filed by Datex-ohmeda Inc., A Division Of Instrumentarium C with the FDA for Engstrom Carestation, Engstrom Pro.

Pre-market Notification Details

Device IDK093886
510k NumberK093886
Device Name:ENGSTROM CARESTATION, ENGSTROM PRO
ClassificationVentilator, Continuous, Facility Use
Applicant DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C 3030 OHMEDA DRIVE Madison,  WI  53718 -6794
ContactJim Raskob
CorrespondentJim Raskob
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C 3030 OHMEDA DRIVE Madison,  WI  53718 -6794
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-18
Decision Date2010-05-03
Summary:summary

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