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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 K903702
Device Name MODEL 90421 FLEXPORT INTERFACE
Applicant
SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Applicant Contact RAYMOND W GIFFORD
Correspondent
SPACELABS, INC.
15220 N.E. 40TH ST.
P.O. BOX 97013
REDMOND,  WA  98073 -9713
Correspondent Contact RAYMOND W GIFFORD
Regulation Number870.2700
Classification Product Code
DQA  
Date Received07/31/1990
Decision Date 10/19/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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