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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 K183394
Device Name CARESCAPE Respiratory Modules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO
Applicant
GE HealthCare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FI-00510
Applicant Contact Joel Kent
Correspondent
GE HealthCare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FI-00510
Correspondent Contact Anna Pehrsson
Regulation Number868.1400
Classification Product Code
CCK  
Subsequent Product Codes
BZK   BZL   CAP   CBQ   CBR  
CBS   CCL   NHO   NHP   NHQ  
Date Received12/07/2018
Decision Date 05/01/2019
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
Recalls CDRH Recalls
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