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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 K811102
Device Name SIEMENS-ELEMA AB SERVO VENTILATOR 900 C
Applicant
SIEMENS ELEMA AB
4221 Richmond Rd., N.W.
Walker,  MI  49534
Correspondent
SIEMENS ELEMA AB
4221 Richmond Rd., N.W.
Walker,  MI  49534
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/21/1981
Decision Date 05/05/1981
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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