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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 (SE)
Classification Advisory Committee Anesthesiology
Review Advisory Committee Anesthesiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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