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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
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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