Cleared Traditional

MR Conditional CGA 870

K162811 · Essex Industries, Inc. · Anesthesiology

Mar 2017

Decision

147d

Days

Class 1

Risk

About This 510(k) Submission

K162811 is an FDA 510(k) clearance for the MR Conditional CGA 870, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on March 2, 2017, 147 days after receiving the submission on October 6, 2016. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K162811 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 06, 2016
Decision Date	March 02, 2017
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF