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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name computer, diagnostic, programmable
510(k) Number K063490
Device Name SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Applicant Contact DAVID J GERAGHTY
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Correspondent Contact DAVID J GERAGHTY
Regulation Number870.1425
Classification Product Code
DQK  
Date Received11/17/2006
Decision Date 03/15/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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