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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 K201941
Device Name Monitor B125, Monitor B105
Applicant
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
milwaukee,  WI  53223
Applicant Contact joel kent
Correspondent
GE Medical Systems Information Technologies, Inc.
8200 West Tower Avenue
milwaukee,  WI  53223
Correspondent Contact joel kent
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CBQ   CBR   CBS   CCK  
CCL   DPZ   DQA   DQK   DRT   DSI  
DSJ   DSK   DXN   FLL   GWQ   KRB  
MLD   NHO   NHP   NHQ   OLT   OLW  
OMC   ORT  
Date Received07/13/2020
Decision Date 11/04/2020
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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