Cleared Traditional

K131021 - PULSE OXIMETER (FDA 510(k) Clearance)

K131021 · Nonin Medical, Inc. · Anesthesiology device

Sep 2013

Decision

152d

Days

Class 2

Risk

K131021 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 September 11, 2013, 152 days after receiving the submission on April 12, 2013.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 870.2700.

Submission Details

510(k) Number	K131021 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 12, 2013
Decision Date	September 11, 2013
Days to Decision	152 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF