Cleared Traditional

K191403 - Pulse Oximeter (FDA 510(k) Clearance)

K191403 · Nonin Medical, Inc. · Anesthesiology device

Dec 2019

Decision

210d

Days

Class 2

Risk

K191403 is an FDA 510(k) clearance for the Pulse Oximeter. This device is classified as 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 FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K191403 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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