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510(k) K242455

AViTA Pulse Oximeter (SP62B) by Avita Corporation — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 19, 2025
Date Received
August 19, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oximeter
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Other clearances by Avita Corporation

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
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  • K242193 — Arm Type Blood Pressure Monitor (BPM82) (October 22, 2024)
  • K223399 — AViTA Pulse Oximeter (May 20, 2024)
  • K200346 — Wrist Type Blood Pressure Monitor (December 17, 2020)
  • 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 DQA

  • K252448 — AViTA Pulse Oximeter (SP61) (February 27, 2026)
  • K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) (February 17, 2026)
  • K253109 — Reusable SPO2 Sensor (BSA307-47; BSA109-50; BSA109-31O) (January 7, 2026)
  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)
  • K250931 — Unimed Reusable SpO2 Sensors (-117 and -121 Series) (U403-117); Unimed Reusable (August 13, 2025)