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510(k) K243115

Upper Arm Electronic Blood Pressure Monitor (U87Y series (models including U80Y, U81Y, U82Y,U83Y,U86Y U80N, U81NH), U86E series (including U82E, U80E, U80EH, U81E, U83E, U85E, U80L, U87E ), U81X series (including U81X, U80X, U82X, U83X, U81D, U82D, U83D, U81RH, U82RH) and U83Z series (including U83Z, U80Z, U81Z, U82Z, U85Z, U86Z and U87Z)) by Shenzhen Urion Technology Co., Ltd. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 21, 2025
Date Received
September 30, 2024
Clearance Type
Traditional
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 Shenzhen Urion Technology Co., Ltd.

  • K250046 — Air Compression Leg Massager (UM605, UM606, UM607, UM608,UM609,UM610, UM611, UM6 (April 25, 2025)
  • K241007 — Upper Arm Electronic Blood Pressure Monitor (U86E and TelliBP01) (October 24, 2024)
  • K200802 — Infrared Thermometer (October 7, 2020)
  • K160019 — U80 Series Upper Arm Electronic Blood Pressure Monitor (April 22, 2016)
  • K141683 — ELECTRONIC BLOOD PRESSURE MONITOR (April 3, 2015)

Other clearances for product code DXN

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  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (February 13, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K251307 — Clinical Automatic Blood Pressure Monitor (DBP-20,DBP-20i) (January 12, 2026)
  • K253142 — Arm Blood Pressure Monitor (MJ1D,MJ1DS,MJ3D,MJ5D,MJ6D,MJ8D,RN3D,MJ4D,RN1D,RN2D) (January 9, 2026)
  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
  • K251795 — Wrist automatic blood pressure monitor (LD-735, LD-752, LD-753) (October 9, 2025)