ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000

Ventilator, Continuous, Facility Use

DATEX-OHMEDA

The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Engstrom Carestation, Engstrom Pro, Models 1505-9000-000, 1505-9003-000.

Pre-market Notification Details

Device IDK111116
510k NumberK111116
Device Name:ENGSTROM CARESTATION, ENGSTROM PRO, MODELS 1505-9000-000, 1505-9003-000
ClassificationVentilator, Continuous, Facility Use
Applicant DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison,  WI  53707
ContactMonica Morrison
CorrespondentMonica Morrison
DATEX-OHMEDA PO BOX 7550 3030 OHMEDA DR Madison,  WI  53707
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-04-21
Decision Date2011-09-09
Summary:summary

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