Cleared Traditional

K060265 - REMCORE REMOTE CONTROLLED OXYGEN REGULATOR
(FDA 510(k) Clearance)

K060265 · Remcore, Inc. · Anesthesiology

Oct 2006

Decision

266d

Days

Class 1

Risk

K060265 is an FDA 510(k) clearance for the REMCORE REMOTE CONTROLLED OXYGEN REGULATOR, a Regulator, Pressure, Gas Cylinder (Class I — General Controls, product code CAN), submitted by Remcore, Inc. (Boston, US). The FDA issued a Cleared decision on October 25, 2006, 266 days after receiving the submission on February 1, 2006. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.2700.

Submission Details

510(k) Number	K060265 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 01, 2006
Decision Date	October 25, 2006
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	Statement