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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Display, Cathode-Ray Tube, Medical
510(k) Number K932724
Device Name SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAY
Applicant
Spacelabs Medical, Inc.
15220 N. E. 40th St.
P.O. Box 97013
Redmond,  WA  98052
Applicant Contact RAYMOND W GIFFORD
Correspondent
Spacelabs Medical, Inc.
15220 N. E. 40th St.
P.O. Box 97013
Redmond,  WA  98052
Correspondent Contact RAYMOND W GIFFORD
Regulation Number870.2450
Classification Product Code
DXJ  
Date Received06/07/1993
Decision Date 11/05/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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