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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 K901209
Device Name MODEL 90489 PULSE OXIMETER MODULE
Original Applicant
SPACELABS, INC.
15220 n.e. 40th st.
p.o. box 97013
redmond,  WA  98073 -9713
Original Contact w gifford
Regulation Number870.2700
Classification Product Code
DQA  
Date Received03/14/1990
Decision Date 04/30/1990
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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