MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP


Device Classification Name

pump, infusion, insulin

510(k) Number K022831
Device Name MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP
Original Applicant
DISETRONIC MEDICAL SYSTEMS AG
kirchberstrasse 190, postfach
burgdorf, 

SE

ch-3401

Original Contact sandra soniec
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 08/26/2002
Decision Date 09/11/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

General Hospital

510k Review Panel

General Hospital

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls