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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 K191106
Device Name C50 and C80 Multi-parameter Patient Monitor
Applicant
Shenzhen Comen Medical Instruments Co.,Ltd
Floor 11 And Section C Of Floor 12 Of Bldg. 1a & Floor 1
To Floor 5 Of Bldg. 2, Fiyta Timepiece Bldg, Nanhuan Ave.
Shenzhen,  CN 518106
Applicant Contact Hongbo Yan
Correspondent
Shenzhen Comen Medical Instruments Co.,Ltd
Floor 11 And Section C Of Floor 12 Of Bldg. 1a & Floor 1
To Floor 5 Of Bldg. 2, Fiyta Timepiece Bldg, Nanhuan Ave.
Shenzhen,  CN 518106
Correspondent Contact Hongbo Yan
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DPS   DQA   DRT   DSB   DSI   DSJ  
DSK   DXG   DXN   FLL   GXY   MLD  
NHO   NHP   NHQ   OLW  
Date Received04/25/2019
Decision Date 12/13/2019
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
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