510(k) K021725

DISETRONIC D-TRON INSULIN INFUSION PUMP by Disetronic Medical Systems AG — Product Code LZG

K021725 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "DISETRONIC D-TRON INSULIN INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on August 2, 2002. The device falls under product code LZG (Pump, Infusion, Insulin), a Class II device regulated under 21 CFR 880.5725. Disetronic Medical Systems AG has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 2002
Date Received
May 24, 2002
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