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510(k) K160231

Model X-100C CO-Met™ Oximetry System by Nonin Medical, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2016
Date Received
February 1, 2016
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 Nonin Medical, Inc.

  • K211498 — Nonin OTC Pulse Oximeter Model 3250 (November 13, 2024)
  • K192900 — H500 Multi-Sensing Oximetry System (June 29, 2020)
  • K191403 — Pulse Oximeter (December 20, 2019)
  • 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)
  • 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)
  • K131021 — PULSE OXIMETER (September 11, 2013)

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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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