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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 K171028
Device Name CARESCAPE Respiratory MOdules, E-sCO, E-sCOV, E-sCOVX, E-sCAiO, E-sCAiOV, E-sCAiOVX and accessories
Applicant
GE Healthcare Finland OY
Kuortaneenkatu 2
Helsinki,  FI FI-00510
Applicant Contact Anna Pehrsson
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 Received04/05/2017
Decision Date 08/17/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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