Home / 510(k) Clearances / K211498

510(k) K211498

Nonin OTC Pulse Oximeter Model 3250 by Nonin Medical, Inc. — Product Code OLK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 13, 2024
Date Received
May 14, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pulse Oximeter For Over-The-Counter Use
Device Class
Class II
Regulation Number
870.2700
Review Panel
AN
Submission Type

Non-wearable, fingertip pulse oximeter intended for over-the-counter use for non-continuous monitoring

Other clearances by Nonin Medical, Inc.

  • 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)
  • 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)
  • K131021 — PULSE OXIMETER (September 11, 2013)

Other clearances for product code OLK

  • K214115 — MightySat -OTC (January 31, 2024)