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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, Carbon-Dioxide, Gaseous-Phase
510(k) Number K130112
Device Name CAPNO MODULE, 92517
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 Number868.1400
Classification Product Code
CCK  
Date Received01/16/2013
Decision Date 03/21/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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