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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
Applicant
SPACELABS MEDICAL, INC.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Applicant Contact NANCY GERTLAR
Correspondent
SPACELABS MEDICAL, INC.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Correspondent 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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