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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 K112840
Device Name CAPNODURA COMBI & CAPNODURA PEDI CO2 DETECTOR
Applicant
SEEBREATH AB
MORKULLEVAGEN 31
BJARRED,  SE 23736
Applicant Contact ANETTE SJOGREN
Correspondent
SEEBREATH AB
MORKULLEVAGEN 31
BJARRED,  SE 23736
Correspondent Contact ANETTE SJOGREN
Regulation Number868.1400
Classification Product Code
CCK  
Date Received09/29/2011
Decision Date 07/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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