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510(k) K242193

Arm Type Blood Pressure Monitor (BPM82) by Avita Corporation — Product Code DXN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 22, 2024
Date Received
July 26, 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

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  • K180155 — Arm Type Blood Pressure Monitor (August 3, 2018)
  • K172427 — AViTA Radar Thermo NT16 Series IR Thermometer (April 19, 2018)
  • K112825 — AVITA ARM TYPE BLOOD PRESSURE MONITOR (January 18, 2012)
  • K110559 — AVITA INFRARED THEROMETER WITH BLUETOOTH (January 6, 2012)

Other clearances for product code DXN

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  • 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)