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510(k) K083010

SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR by Shenzhen Med-Link Electronics Tech Co., Ltd. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 10, 2009
Date Received
October 9, 2008
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 Shenzhen Med-Link Electronics Tech Co., Ltd.

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  • K220447 — Med-link Disposable ECG Cable and Leadwires (June 28, 2022)
  • K212752 — Med-link Pulse Oximeter (May 20, 2022)
  • K210441 — Incontinence Probe (September 17, 2021)
  • K202743 — Med-Link Temp-pulse Oximeter (March 1, 2021)
  • K193338 — Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes (August 25, 2020)
  • K181154 — Med-link Wrist Digital Blood Pressure Monitor, Med-link Upper Arm Digital Blood (August 2, 2019)
  • K182667 — Med-link Temperature Probes (June 18, 2019)
  • K173869 — Med-link Reusable Blood Pressure Cuff (August 2, 2018)

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)