DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP


Device Classification Name

pump, infusion, insulin

510(k) Number K023471
Device Name DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP
Original Applicant
DISETRONIC MEDICAL SYSTEMS AG
5151 program ave.
st. paul, 
MN 
55112 -1014

Original Contact david e chadwick
Regulation Number 880.5725
Classification Product Code
LZG  
Date Received 10/15/2002
Decision Date 10/29/2002
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