510(k) K023471

DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP by Disetronic Medical Systems AG — Product Code LZG

K023471 is an FDA 510(k) premarket notification submitted by Disetronic Medical Systems AG for the device "DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP". The FDA issued a decision of Substantially Equivalent on October 29, 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
October 29, 2002
Date Received
October 15, 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