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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name analyzer, gas, nitrous-oxide, gaseous phase (anesthetic conc.)
510(k) Number K053599
Device Name SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSORIES
Applicant
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Applicant Contact AL VAN HOUDT
Correspondent
SPACELABS MEDICAL INC.
5150 220TH AVE SE
ISSAQUAH,  WA  98029
Correspondent Contact AL VAN HOUDT
Regulation Number868.1700
Classification Product Code
CBR  
Date Received12/23/2005
Decision Date 04/19/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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