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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Oximeter, Ear
510(k) Number K850494
Device Name OHMEDA BIOX 3700 PULSE OXIMETER
Applicant
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Applicant Contact KENNETH D NICHOLS
Correspondent
OHMEDA MEDICAL
OHMEDA DRIVE, P.O. BOX 7550
MADISON,  WI  53707 -7550
Correspondent Contact KENNETH D NICHOLS
Regulation Number870.2710
Classification Product Code
DPZ  
Date Received02/08/1985
Decision Date 03/28/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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