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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 K260260
Device Name Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569)
Applicant
Honsun (Nantong) Co., Ltd.
#8 Tongxing Rd., Economic & Technological, Development Area
Nantong,  CN 226009
Applicant Contact Jian Shen
Correspondent
Honsun (Nantong) Co., Ltd.
#8 Tongxing Rd., Economic & Technological, Development Area
Nantong,  CN 226009
Correspondent Contact Jian Shen
Regulation Number870.1130
Classification Product Code
DXN  
Date Received01/28/2026
Decision Date 04/28/2026
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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