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510(k) K083079

QUANTA PULSE OXIMETER, MODEL: PULSE LINK 1000 OR QH100 by Quanta Computer, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2009
Date Received
October 16, 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 Quanta Computer, Inc.

  • K231855 — QOCA® image Smart RT Contouring System (February 13, 2024)
  • K221868 — QOCA image Smart CXR Image Processing System (January 27, 2023)
  • K210179 — QOCA Portable ECG Monitoring Device (August 2, 2022)
  • K083078 — QUANTA BLOOD PRESSURE METER, MODEL: CARDIAC ELITE 1000 OR QH200 (November 26, 2008)

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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)