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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 K902758
Device Name COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC
Applicant
COBE LABORATORIES, INC.
14401 WEST 56TH WAY
ARVADA,  CO  80004
Applicant Contact MARY L ARMSTRONG
Correspondent
COBE LABORATORIES, INC.
14401 WEST 56TH WAY
ARVADA,  CO  80004
Correspondent Contact MARY L ARMSTRONG
Regulation Number870.2700
Classification Product Code
DQA  
Date Received06/25/1990
Decision Date 08/23/1990
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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