Cleared Traditional

SuperNO2VA Device

K163277 · Revolutionary Medical Devices, Inc. · Anesthesiology

Oct 2017

Decision

326d

Days

Class 1

Risk

About This 510(k) Submission

K163277 is an FDA 510(k) clearance for the SuperNO2VA Device, a Mask, Gas, Anesthetic (Class I — General Controls, product code BSJ), submitted by Revolutionary Medical Devices, Inc. (Tucson, US). The FDA issued a Cleared decision on October 13, 2017, 326 days after receiving the submission on November 21, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5550.

Submission Details

510(k) Number	K163277 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2016
Decision Date	October 13, 2017
Days to Decision	326 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF