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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name gas-machine, anesthesia
510(k) Number K913791
Device Name OHMEDA 7800 ANESTHESIA VENTILATOR
Applicant
OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP
P.O. BOX 7550
OHMEDA DRIVE
MADISON,  WI  53707
Applicant Contact TIMOTHY M DAVIS
Correspondent
OHMEDA ANESTHESIA SYSTEMS THERAPY GROUP
P.O. BOX 7550
OHMEDA DRIVE
MADISON,  WI  53707
Correspondent Contact TIMOTHY M DAVIS
Regulation Number868.5160
Classification Product Code
BSZ  
Date Received08/23/1991
Decision Date 04/08/1993
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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