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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 K910847
Device Name OHMEDA 7810 ANESTHESIA VENTILATOR
Applicant
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact TIMOTHY M DAVIS
Correspondent
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact TIMOTHY M DAVIS
Regulation Number868.5895
Classification Product Code
CBK  
Date Received02/26/1991
Decision Date 05/03/1991
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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