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510(k) K260260

Automatic Digital Blood Pressure Monitor (LD-587, LD-528, LD-562, LD-581, LD-521, LD-527, LD-572 & LD-569) by Honsun (Nantong) Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2026
Date Received
January 28, 2026
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Measurement, Blood-Pressure, Non-Invasive
Device Class
Class II
Regulation Number
870.1130
Review Panel
CV
Submission Type

Other clearances by Honsun (Nantong) Co., Ltd.

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  • K192500 — Aneroid sphygmomanometer with stethoscope, Aneroid sphygmomanometer (April 6, 2020)
  • K170866 — Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 (February 21, 2018)
  • K170466 — Automatic Blood Pressure Monitor Model LD-518 & LD-537 (October 27, 2017)
  • K170454 — Automatic Blood Pressure Monitor Model LD-562U, LD-588U & LD-533U (October 25, 2017)
  • K132627 — AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR (October 23, 2013)
  • K130925 — AUTOMATIC BLOOD PRESSURE MONITOR (September 12, 2013)
  • K131463 — WRIST AUTOMATIC BLOOD PRESSURE MONITOR (July 8, 2013)
  • K092245 — ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE, MODEL LD-100 (October 28, 2009)

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