Cleared Traditional

K102350 - PULSE OXIMETER (FDA 510(k) Clearance)

K102350 · Nonin Medical, Inc. · Anesthesiology device

Dec 2010

Decision

125d

Days

Class 2

Risk

K102350 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 December 22, 2010, 125 days after receiving the submission on August 19, 2010.

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

Submission Details

510(k) Number	K102350 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 2010
Decision Date	December 22, 2010
Days to Decision	125 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF