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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 K893867
Device Name CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULE
Applicant
SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Applicant Contact RAYMOND GIFFORD
Correspondent
SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Correspondent Contact RAYMOND GIFFORD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received05/26/1989
Decision Date 09/13/1989
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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