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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name monitor, physiological, patient(with arrhythmia detection or alarms)
510(k) Number K191149
Device Name CARESCAPE B650
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 Joel Kent
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZK   BZL   BZQ   CAP   CBQ  
CBR   CBS   CCK   CCL   DPS   DPZ  
DQA   DQK   DRT   DSI   DSJ   DSK  
DXG   DXN   FLL   GWJ   GWQ   KOI  
KRB   MLD   NHO   NHP   NHQ   OLT  
OLW   OMC   ORT  
Date Received04/30/2019
Decision Date 01/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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