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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 K841393
Device Name AB MANUAL VENTILATION ACCESS. 900C
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 Received04/03/1984
Decision Date 05/21/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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