Cleared Traditional

K160231 - Model X-100C CO-Met™ Oximetry System (FDA 510(k) Clearance)

K160231 · Nonin Medical, Inc. · Anesthesiology device

Dec 2016

Decision

326d

Days

Class 2

Risk

K160231 is an FDA 510(k) clearance for the Model X-100C CO-Met™ Oximetry System. 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 23, 2016, 326 days after receiving the submission on February 1, 2016.

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

Submission Details

510(k) Number	K160231 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 01, 2016
Decision Date	December 23, 2016
Days to Decision	326 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF