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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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