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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 K873199
Device Name OHMEDA 4700 OXICAP MONITOR
Applicant
OHMEDA MEDICAL
4765 WALNUT ST.
BOULDER,  CO  80301
Applicant Contact KEN KIYAMA
Correspondent
OHMEDA MEDICAL
4765 WALNUT ST.
BOULDER,  CO  80301
Correspondent Contact KEN KIYAMA
Regulation Number870.2700
Classification Product Code
DQA  
Date Received08/13/1987
Decision Date 02/02/1988
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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