Cleared Traditional

K140785 - PULSE OXIMETER (FDA 510(k) Clearance)

K140785 · Nonin Medical, Inc. · Anesthesiology device

Jul 2014

Decision

98d

Days

Class 2

Risk

K140785 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 July 7, 2014, 98 days after receiving the submission on March 31, 2014.

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

Submission Details

510(k) Number	K140785 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 31, 2014
Decision Date	July 07, 2014
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF