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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 K211619
Device Name Multi-Parameter Patient Monitor
Applicant
Shenzhen Comen Medical Instruments CO., LTD.
FIYTA Timepiece Building, Nanhuan Avenue, Matian
Sub-District, Guangming District
Shenzhen,  CN 51806
Applicant Contact Hongbo Yan
Correspondent
Shenzhen Comen Medical Instruments CO., LTD.
Floor 7 of YIBO Building, FangYuan Road
Matian Sub-District, Guangming District
Shenzhen,  CN 518106
Correspondent Contact Charlotte Lin Jingfang
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CBQ   CBS   CCK   CCL   DPS  
DQA   DRT   DSB   DSI   DSJ   DSK  
DXG   DXN   FLL   GXY   MLD   NHO  
NHP   NHQ   OLW  
Date Received05/26/2021
Decision Date 12/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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