Cleared Traditional

THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN

K131023 · Medical Products, LLC · Anesthesiology

Oct 2013

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K131023 is an FDA 510(k) clearance for the THERAFLOW SINGLE LUMEN AND THERAFLOW DUAL LUMEN, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Medical Products, LLC (Indianapolis, US). The FDA issued a Cleared decision on October 11, 2013, 182 days after receiving the submission on April 12, 2013. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K131023 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 12, 2013
Decision Date	October 11, 2013
Days to Decision	182 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement