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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 Dr.
P.O. Box 7550
Madison,  WI  53707
Applicant Contact KENNETH D NICHOLS
Correspondent
Ohmeda Medical
Ohmeda Dr.
P.O. Box 7550
Madison,  WI  53707
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
Predetermined Change
Control Plan Authorized		 No
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