Cleared Traditional

FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS

K111669 · Insulet Corporation · General Hospital

Dec 2011

Decision

183d

Days

Class 2

Risk

About This 510(k) Submission

K111669 is an FDA 510(k) clearance for the FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS, a Pump, Infusion, Insulin (Class II — Special Controls, product code LZG), submitted by Insulet Corporation (Bedford, US). The FDA issued a Cleared decision on December 15, 2011, 183 days after receiving the submission on June 15, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5725.

Submission Details

510(k) Number	K111669 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 15, 2011
Decision Date	December 15, 2011
Days to Decision	183 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF