Cleared Special

K113111 - CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION
(FDA 510(k) Clearance)

K113111 · Inovo, Inc. · Anesthesiology

Dec 2011

Decision

49d

Days

Class 2

Risk

K113111 is an FDA 510(k) clearance for the CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION, a Conserver, Oxygen (Class II — Special Controls, product code NFB), submitted by Inovo, Inc. (Naples, US). The FDA issued a Cleared decision on December 8, 2011, 49 days after receiving the submission on October 20, 2011. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5905.

Submission Details

510(k) Number	K113111 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 20, 2011
Decision Date	December 08, 2011
Days to Decision	49 days
Submission Type	Special
Review Panel	Anesthesiology (AN)
Summary	Summary PDF