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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Measurement, Blood-Pressure, Non-Invasive
510(k) Number K243661
Device Name Electronic Blood Pressure Monitor
Applicant
Hetaida Technology Co., Ltd.
Rm.801, 802, 803, 804, 901, 2# Bldg. Scientific Research Ctr
Songhu Intelligent Valley, #6 Minfu Rd., Liaobu Town
Dongguan City,  CN 523423
Applicant Contact Tom Chen
Correspondent
Hetaida Technology Co., Ltd.
Rm.801, 802, 803, 804, 901, 2# Bldg. Scientific Research Ctr
Songhu Intelligent Valley, #6 Minfu Rd., Liaobu Town
Dongguan City,  CN 523423
Correspondent Contact Tom Chen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received11/27/2024
Decision Date 02/07/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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