Cleared Traditional

CYL-FIL OXYGEN SYSTEM

K061785 · Responsive Respiratory, Inc. · Anesthesiology

Sep 2006

Decision

76d

Days

Class 1

Risk

About This 510(k) Submission

K061785 is an FDA 510(k) clearance for the CYL-FIL OXYGEN SYSTEM, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Responsive Respiratory, Inc. (St. Louis, US). The FDA issued a Cleared decision on September 7, 2006, 76 days after receiving the submission on June 23, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K061785 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2006
Decision Date	September 07, 2006
Days to Decision	76 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF