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510(k) K102350

PULSE OXIMETER by Nonin Medical, Inc. — Product Code DQA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2010
Date Received
August 19, 2010
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

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  • K160231 — Model X-100C CO-Met™ Oximetry System (December 23, 2016)
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  • 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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  • K251693 — Unimed Reusable SpO2 Sensors (-75 Series) (U410-75); Unimed Reusable SpO2 Sensor (November 18, 2025)
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