SERVO VENTILATOR 900D SIEMENS-ELEMA AB

Ventilator, Continuous, Facility Use

SIEMENS ELEMA AB

The following data is part of a premarket notification filed by Siemens Elema Ab with the FDA for Servo Ventilator 900d Siemens-elema Ab.

Pre-market Notification Details

Device IDK844912
510k NumberK844912
Device Name:SERVO VENTILATOR 900D SIEMENS-ELEMA AB
ClassificationVentilator, Continuous, Facility Use
Applicant SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
ContactChrister Hellsten
CorrespondentChrister Hellsten
SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
Product CodeCBK  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-18
Decision Date1984-12-28

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