FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS


Device Classification Name

pump, infusion, insulin

510(k) Number K111669
Device Name FREESTYLE GLUCOSE METER INCORPORATED INTO THE OMNIPOD INSULIN MANAGEMENT SYSTEMS
Applicant
INSULET CORPORATION
9 oak park dr.
bedford, 
MA 
01730

Applicant Contact susan finneran
Correspondent
INSULET CORPORATION
9 oak park dr.
bedford, 
MA 
01730

Correspodent Contact susan finneran
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 06/15/2011
Decision Date 12/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No