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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 K202336
Device Name Patient Monitor
Applicant
Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District Pingshan District
Shenzhen,  CN 518122
Applicant Contact Alice Yang
Correspondent
Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community,
Kengzi Sub-District Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Alice Yang
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
BZQ   CBQ   CBR   CBS   CCK  
CCL   DPS   DQA   DRT   DSI   DSK  
DXN   FLL   MLD   NHO   NHP   NHQ  
Date Received08/17/2020
Decision Date 01/23/2021
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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