Cleared Traditional

K112843 - PULSE OXIMETER (FDA 510(k) Clearance)

K112843 · Nonin Medical, Inc. · Anesthesiology device

Apr 2012

Decision

203d

Days

Class 2

Risk

K112843 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 April 19, 2012, 203 days after receiving the submission on September 29, 2011.

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

Submission Details

510(k) Number	K112843 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 29, 2011
Decision Date	April 19, 2012
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF