Cleared Traditional

Pulse Oximeter

K191403 · Nonin Medical, Inc. · Anesthesiology
Dec 2019
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K191403 is an FDA 510(k) clearance for the Pulse Oximeter, a Oximeter (Class II — Special Controls, product code DQA), submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on December 20, 2019, 210 days after receiving the submission on May 24, 2019. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number K191403 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 2019
Decision Date December 20, 2019
Days to Decision 210 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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