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510(k) K222887

Arm Blood Pressure Monitor/Automatic Wireless Smart Blood Pressure Monitor by Famidoc Technology Company Limited — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2023
Date Received
September 23, 2022
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 Famidoc Technology Company Limited

  • K233192 — Wireless Smart Thermometer (April 5, 2024)
  • K191673 — Upper Arm Blood Pressure Monitor (November 27, 2019)

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  • K253133 — Wrist Blood Pressure Monitor (BPM-W1VL) (February 13, 2026)
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  • K251143 — Arm Blood Pressure Monitor (MJ1L, MJ2L, RN3L, RN4L,RN5L) (December 19, 2025)
  • K251331 — Blood Pressure Monitor (B73, BE23T) (October 27, 2025)
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