Cleared Traditional

K132402 - SENSMART MODEL X-100 UNIVERAL OXIMETRY SYSTEM (FDA 510(k) Clearance)

K132402 · Nonin Medical, Inc. · Anesthesiology device

Feb 2014

Decision

204d

Days

Class 2

Risk

K132402 is an FDA 510(k) clearance for the SENSMART MODEL X-100 UNIVERAL 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 February 21, 2014, 204 days after receiving the submission on August 1, 2013.

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

Submission Details

510(k) Number	K132402 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 01, 2013
Decision Date	February 21, 2014
Days to Decision	204 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF