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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 K150245
Device Name CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX
Applicant
GE HEALTHCARE FINLAND OY
KUORTANEENKATU 2
HELSINKI,  FI FIN-00510
Applicant Contact Mari Salmenkaita
Correspondent
GE HEALTHCARE FINLAND OY
KUORTANEENKATU 2
HELSINKI,  FI FIN-00510
Correspondent Contact Mari Salmenkaita
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
BZK   BZL   CAP   CBQ   CBR  
CBS   CCL   NHO   NHP   NHQ  
Date Received02/02/2015
Decision Date 07/17/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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