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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer, Diagnostic, Programmable
510(k) Number K251591
Device Name Holter ECG and ABP system (HolterABP)
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan Distrct
Shenzhen,  CN 518122
Applicant Contact Tracy Yue
Correspondent
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District
Pingshan Distrct
Shenzhen,  CN 518122
Correspondent Contact Tracy Yue
Regulation Number870.1425
Classification Product Code
DQK  
Date Received05/23/2025
Decision Date 02/09/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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