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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
Recalls CDRH Recalls
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