DISETRONIC D-TRON INSULIN INFUSION PUMP


Device Classification Name

pump, infusion, insulin

510(k) Number K021725
Device Name DISETRONIC D-TRON INSULIN INFUSION PUMP
Original Applicant
DISETRONIC MEDICAL SYSTEMS AG
kirchberstrasse 190, postfach
burgdorf, 

CH

ch-3401

Original Contact sandra soniec
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 05/24/2002
Decision Date 08/02/2002
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