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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name oximeter
510(k) Number K874104
Device Name OHMEDA BIOX 3760 PULSE OXIMETER
Applicant
OHMEDA MEDICAL
4765 WALNUT ST.
BOULDER,  CO  80301
Applicant Contact NEILL DOERTENBACH
Correspondent
OHMEDA MEDICAL
4765 WALNUT ST.
BOULDER,  CO  80301
Correspondent Contact NEILL DOERTENBACH
Regulation Number870.2700
Classification Product Code
DQA  
Date Received10/08/1987
Decision Date 12/03/1987
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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