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510(k) K151206

Fingertip Pulse Oximeter by Beijing Choice Electronic Technololgy Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2015
Date Received
May 6, 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 Technololgy Co., Ltd.

  • K160508 — Electronic Pulse Stimulator (November 21, 2016)
  • K142888 — Fingertip Pulse Oximeter (February 20, 2015)
  • K141024 — EXTERNAL PULSE OXIMETER (January 13, 2015)
  • K141128 — FINGERTIP PULSE OXIMETER (August 13, 2014)
  • K140682 — FINGERTIP PULSE OXIMETER (July 17, 2014)
  • K131047 — FINGERTIP PULSE OXIMETER (October 16, 2013)
  • K130947 — FINGERTIP PULSE OXIMETER (October 3, 2013)
  • K123871 — FINGERTIP PULSE OXIMETER (May 10, 2013)
  • K122046 — WRIST PULSE OXIMETER (February 4, 2013)
  • K112622 — HANDHELD ECG MONITOR (July 19, 2012)

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  • 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)