510(k) K120206

MEDTRONIC MINIMED PARADIGM INSULIN PUMPS by Medtronic Minimed — Product Code LZG

K120206 is an FDA 510(k) premarket notification submitted by Medtronic Minimed for the device "MEDTRONIC MINIMED PARADIGM INSULIN PUMPS". The FDA issued a decision of Substantially Equivalent on March 29, 2012. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Medtronic Minimed has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2012
Date Received
January 23, 2012
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type