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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 K213490
Device Name Monitor B105M, Monitor B125M, Monitor B155M, Monitor B105P, Monitor B125P
Applicant
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
Applicant Contact Joel Kent
Correspondent
Ge Medical Systems Information Technologies, Inc.
9900 Innovation Dr.
Wauwatosa,  WI  53226
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   KOI  
KRB   MLD   NHO   NHP   NHQ   OLT  
OLW   OMC   ORT  
Date Received11/01/2021
Decision Date 04/01/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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