Cleared Traditional

K161472 - Walk-O2-Bout
(FDA 510(k) Clearance)

K161472 · Essex Industries, Inc. · Anesthesiology

Nov 2016

Decision

175d

Days

Class 1

Risk

K161472 is an FDA 510(k) clearance for the Walk-O2-Bout. This device is classified as a Cylinder, Compressed Gas, And Valve (Class I — General Controls, product code ECX).

Submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on November 18, 2016, 175 days after receiving the submission on May 27, 2016.

This device falls under the Anesthesiology FDA review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K161472 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2016
Decision Date	November 18, 2016
Days to Decision	175 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF