DATA EXCHANGE SYSTEM, MODEL 24

Ventilator, Continuous, Facility Use

SIEMENS LIFE SUPPORT SYSTEMS

The following data is part of a premarket notification filed by Siemens Life Support Systems with the FDA for Data Exchange System, Model 24.

Pre-market Notification Details

Device IDK890921
510k NumberK890921
Device Name:DATA EXCHANGE SYSTEM, MODEL 24
ClassificationVentilator, Continuous, Facility Use
Applicant SIEMENS LIFE SUPPORT SYSTEMS P.O. BOX 68517 Schaumberg,  IL  60168
ContactEllen Farney
CorrespondentEllen Farney
SIEMENS LIFE SUPPORT SYSTEMS P.O. BOX 68517 Schaumberg,  IL  60168
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-02-24
Decision Date1989-06-08

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