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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 K251508
Device Name Telemetry Monitor (iT30, iT50)
Applicant
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Applicant Contact Tracy Yue
Correspondent
Edan Instruments, Inc.
15 Jinhui Rd., Jinsha Community, Kengzi Sub-District,
Pingshan District,
Shenzhen,  CN 518122
Correspondent Contact Tracy Yue
Regulation Number870.1025
Classification Product Code
MHX  
Subsequent Product Codes
DPS   DQA   DRT   DSB   DXN  
FLL   MLD   MSX  
Date Received05/16/2025
Decision Date 08/06/2026
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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