SERVO VENTILATOR 900 C/D

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 900 C/d.

Pre-market Notification Details

Device IDK871354
510k NumberK871354
Device Name:SERVO VENTILATOR 900 C/D
ClassificationVentilator, Continuous, Facility Use
Applicant SIEMENS ELEMA AB 2360 NORTH PALMER DR. P.O. BOX 94517 Schaumburg,  IL  60195
ContactEllen Farney
CorrespondentEllen Farney
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 Received1987-04-06
Decision Date1987-07-21

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