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510(k) K230649

Arm Blood Pressure Monitor by Alicn Medical Shenzhen, Inc. — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 2023
Date Received
March 9, 2023
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 Alicn Medical Shenzhen, Inc.

  • K232338 — Electronic Thermometer, Model: AET-F331, AET-F332, AET-F333, AET-F344, AET-F345, (December 22, 2023)
  • K231050 — Arm Blood Pressure Monitor (October 11, 2023)
  • K222248 — Infrared Thermometer (June 7, 2023)
  • K221913 — Arm Blood Pressure Monitor (October 12, 2022)
  • K210937 — Electronic Thermometer, Model: AET-F101, AET-F221, AET-F231, AET-F241 (May 12, 2022)
  • K210565 — Infrared Thermometer, Model: AET-R1B1, AET-R161, AET-R171, AET-R1D1, AET-R1D2, A (May 5, 2022)
  • K212257 — Electronic Thermometer, Model: AET-E201, AET-E211, AET-E221, AET-E231, AET-E241, (May 4, 2022)
  • K212877 — Arm Blood Pressure Monitor (January 12, 2022)
  • K210564 — Infrared Thermometer (January 7, 2022)
  • K210563 — Arm Blood Pressure Monitor (October 15, 2021)

Other clearances for product code DXN

  • K254225 — Arm Blood Pressure Monitor (HH-802CB, HH-802EB, HH-805CB, HH-812CB, HH-808CL, HH (April 1, 2026)
  • K260276 — Arm Blood Pressure Monitor Models: ARM-30C+; ARM-30M+; ARM-HA101+; ARM-3060; XS (April 1, 2026)
  • K260273 — Automatic Electronic Blood Pressure Monitor (U90B series models including ( U90B (March 26, 2026)
  • K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR) (March 5, 2026)
  • K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR) (February 23, 2026)
  • K251581 — Wearable Ambulatory Blood Pressure Monitor (WBP-02A) (February 13, 2026)
  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
  • K252685 — Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-61D2L, DBP-61D2L-P, (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)