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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 K851509
Device Name OHMEDA 7000 ELECTRONIC ANESTHESIA VENTILATOR
Applicant
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact RAYMOND T RIDDLE
Correspondent
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact RAYMOND T RIDDLE
Regulation Number868.5895
Classification Product Code
CBK  
Date Received04/15/1985
Decision Date 07/15/1985
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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