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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 K981655
Device Name SPACELABS MEDICAL DISPOSABLE SP02 SENSOR
Original Applicant
SPACELABS MEDICAL, INC.
p.o. box 97013
redmond,  WA  98073 -9713
Original Contact nancy gertlar
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/11/1998
Decision Date 12/03/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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