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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 K871354
Device Name SERVO VENTILATOR 900 C/D
Applicant
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Applicant Contact ELLEN FARNEY
Correspondent
Siemens Elema AB
2360 N. Palmer Dr.
P.O. Box 94517
Schaumburg,  IL  60195
Correspondent Contact ELLEN FARNEY
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/06/1987
Decision Date 07/21/1987
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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