Cleared Traditional

MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3

K101272 · Essex Industries, Inc. · Anesthesiology

Aug 2010

Decision

106d

Days

Class 2

Risk

About This 510(k) Submission

K101272 is an FDA 510(k) clearance for the MASS OXYGEN DISTRIBUTION SYSTEM (MODS) MODEL 10C-0061-3, a Unit, Liquid-oxygen, Portable (Class II — Special Controls, product code BYJ), submitted by Essex Industries, Inc. (St. Louis, US). The FDA issued a Cleared decision on August 20, 2010, 106 days after receiving the submission on May 6, 2010. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5655.

Submission Details

510(k) Number	K101272 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 06, 2010
Decision Date	August 20, 2010
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Summary PDF