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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 K254225
Device Name Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH-808EL)
Applicant
Shenzhen HanHan Technology Co., Ltd.
Bldg. B1,B301,Yingzhan Technology Park,#8 Longtian Tong
Fuyu Rd., Longtian Community, Longtian St., Pingshan Dis
Shenzhen,  CN 518118
Applicant Contact Yong Zhang
Correspondent
Shenzhen HanHan Technology Co., Ltd.
Bldg. B1,B301,Yingzhan Technology Park,#8 Longtian Tong
Fuyu Rd., Longtian Community, Longtian St., Pingshan Dis
Shenzhen,  CN 518118
Correspondent Contact Yong Zhang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received12/29/2025
Decision Date 04/01/2026
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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