Cleared Traditional

Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor

K172625 · Nonin Medical, Inc. · Anesthesiology
May 2018
Decision
252d
Days
Class 2
Risk

About This 510(k) Submission

K172625 is an FDA 510(k) clearance for the Reusable, Finger Clip Nonin Medical CO-Met Oximetry Sensor, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on May 11, 2018, 252 days after receiving the submission on September 1, 2017. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K172625 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 2017
Decision Date May 11, 2018
Days to Decision 252 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DQA — Oximeter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2700

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