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510(k) K092101

REUSABLE PULSE OXIMETER SENSOR, MODEL 8000 SERIES by Nonin Medical, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2009
Date Received
July 14, 2009
Clearance Type
Special
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 Nonin Medical, Inc.

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  • K190560 — SenSmart Model 8006CA Reusable Regional Oximetry Sensor, SenSmart Model 8006PI D (May 2, 2019)
  • K172625 — Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor (May 11, 2018)
  • K160231 — Model X-100C CO-Met™ Oximetry System (December 23, 2016)
  • K160865 — Model 6100C Series Single-Patient Use, Disposable Pulse Oximeter Sensors (6100C (August 5, 2016)
  • K151305 — SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmar (August 27, 2015)
  • K140785 — PULSE OXIMETER (July 7, 2014)
  • K132402 — SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM (February 21, 2014)

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  • K251751 — Spo2 Sensor CSS032D (December 19, 2025)
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  • 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)
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