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510(k) K152563

Pulse Oximeter (MD300M/MD300K2) by Beijing Choice Electronic Technology Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 2016
Date Received
September 9, 2015
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 Beijing Choice Electronic Technology Co., Ltd.

  • K232975 — Pulse Oximeter (MD300C228) (June 21, 2024)
  • K230587 — Wrist Pulse Oximeter (November 30, 2023)
  • K230172 — Pulse Oximeter (August 12, 2023)
  • K220101 — Pulse Oximeter (March 8, 2023)
  • K221992 — Electronic Pulse Stimulator (October 21, 2022)
  • K211400 — Pulse Oximeter (February 11, 2022)
  • K211752 — Infrared Thermometer (January 21, 2022)
  • K211754 — Vital Signs Monitor (November 15, 2021)
  • K181503 — Fingertip Pulse Oximeter (October 11, 2018)
  • K172366 — Wrist Pulse Oximeter (March 16, 2018)

Other clearances for product code DQA

  • K260931 — Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R) (April 14, 2026)
  • 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)
  • K251691 — Unimed Reusable SpO2 Sensors (-08 Series) (U403S-08); Unimed Reusable SpO2 Senso (December 1, 2025)
  • K251696 — Unimed Reusable SpO2 Sensors (-48 Series and -29 Series) (U410-48); Unimed Reusa (December 1, 2025)
  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
  • K251695 — Unimed Reusable SpO2 Sensors (-06 Series) (U403S-06); Unimed Reusable SpO2 Senso (November 18, 2025)
  • K250837 — Pulse Oximeter (September 25, 2025)