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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 K112173
Device Name SPEACELABS MULTIGAS MODULE
Applicant
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND,  CO  80466
Applicant Contact THOMAS KROENKE
Correspondent
SPACELABS HEALTHCARE
P.O. BOX 3018
NEDERLAND,  CO  80466
Correspondent Contact THOMAS KROENKE
Regulation Number868.1700
Classification Product Code
CBR  
Subsequent Product Codes
CBQ   CBS   CCK   CCL   NHO  
NHP   NHQ  
Date Received07/28/2011
Decision Date 10/05/2011
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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