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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name ventilator, continuous, facility use
510(k) Number K884520
Device Name SERVO VENTILATOR 900E
Applicant
SIEMENS-ELEMA VENTILATION SYSTEMS
P.O. BOX 68517
SCHAUMBURG,  IL  60168 -0517
Applicant Contact ELLEN FARNEY
Correspondent
SIEMENS-ELEMA VENTILATION SYSTEMS
P.O. BOX 68517
SCHAUMBURG,  IL  60168 -0517
Correspondent Contact ELLEN FARNEY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received10/27/1988
Decision Date 01/17/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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