510(k) K070438

MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305 by Medtronic Minimed, Inc. — Product Code MRZ

K070438 is an FDA 510(k) premarket notification submitted by Medtronic Minimed, Inc. for the device "MEDTRONIC MINIMED CARELINK USB CONNECTOR, MODEL NMT 7305". The FDA issued a decision of Substantially Equivalent on October 17, 2007. The device falls under product code MRZ (Accessories, Pump, Infusion), a Class II device regulated under 21 CFR 880.5725. Medtronic Minimed, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2007
Date Received
February 15, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Pump, Infusion
Device Class
Class II
Regulation Number
880.5725
Review Panel
HO
Submission Type