Cleared Traditional

Nonin OTC Pulse Oximeter Model 3250

K211498 · Nonin Medical, Inc. · Anesthesiology
Nov 2024
Decision
1279d
Days
Class 2
Risk

About This 510(k) Submission

K211498 is an FDA 510(k) clearance for the Nonin OTC Pulse Oximeter Model 3250, a Pulse Oximeter For Over-the-counter Use (Class II — Special Controls, product code OLK), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 13, 2024, 1279 days after receiving the submission on May 14, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K211498 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 2021
Decision Date November 13, 2024
Days to Decision 1279 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code OLK — Pulse Oximeter For Over-the-counter Use
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700
Definition Non-wearable, Fingertip Pulse Oximeter Intended For Over-the-counter Use For Non-continuous Monitoring