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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 K260276
Device Name Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS Pro; ARM-30G1; ARM-30H; Visomat double comfort; Visomat comfort 20/40 BT; ARM-3080; ARM-3081; ARM-3082; ARM-3103; ARM-3200; ARM-115; ARM-111; ARM-3102; ARM-3100; ARM-3101; SBM 15; ARM-30W; ARM-30J; ARM-30F-XL; ARM-3024-XL; ARM-3025-XL; ARM-3062-XL; 9S Pro
Applicant
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 301&4-5f, Block A, Bldg. A, Jingfa Intelligent
Manuf. Park, Xiaweiyuan, Gushu Comm. Xixiang St. Bao'An Dist
Shenzhen,  CN 518126
Applicant Contact Jack Wang
Correspondent
Shenzhen AOJ Medical Technology Co., Ltd.
Rm. 301&4-5f, Block A, Bldg. A, Jingfa Intelligent
Manuf. Park, Xiaweiyuan, Gushu Comm. Xixiang St. Bao'An Dist
Shenzhen,  CN 518126
Correspondent Contact Jack Wang
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/29/2026
Decision Date 04/01/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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