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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 K213799
Device Name N Series Patient Monitors
Applicant
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Applicant Contact Li Lei
Correspondent
Shenzhen Mindray Bio-medical Electronics Co., LTD.
Mindray Building, Keji 12th Road South
Hi-tech Industrial Park, Nanshan
Shenzhen,  CN 518057
Correspondent Contact Li Lei
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
CBQ   CBR   CBS   CCK   CCL  
DQA   DRG   DRS   DRT   DSB   DSI  
DSJ   DSK   DXG   DXN   FLL   GXY  
KOI   KRC   MLC   MLD   MSX   MUD  
NHO   NHP   NHQ   OLT   OLW   OMC  
ORT  
Date Received12/06/2021
Decision Date 07/12/2022
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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