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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 K223170
Device Name Electronic Blood Pressure Monitor, model: HTD6602US
Applicant
Hetaida Technology Co., Ltd.
Rm.801~804,901, 2# Bldg. Scientific Research Center
Songhu Intelligent Valley, Liaobu Town
Dongguan City,  CN 523423
Applicant Contact Tom Chen
Correspondent
Qimmiq Medical Consulting Service Co., Ltd.
Rm.406, Bldg. C, Run Science Park, #18 Shenzhou Rd.
Huangpu
Guangzhou,  CN 510663
Correspondent Contact You Yijie
Regulation Number870.1130
Classification Product Code
DXN  
Date Received10/11/2022
Decision Date 12/05/2023
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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