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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrocardiograph
510(k) Number K212278
Device Name Electrocardiograph
Applicant
Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen,  CN 518122
Applicant Contact Ying Dai
Correspondent
Edan Instruments, Inc.
#15 Jinhui Road, Jinsha Community, Kengzi Sub-District
Pingshan District
Shenzhen,  CN 518122
Correspondent Contact Joan Wei
Regulation Number870.2340
Classification Product Code
DPS  
Date Received07/20/2021
Decision Date 04/07/2022
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
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