Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K023471 |
Device Name |
DISETRONIC H-TRONPLUS INSULIN INFUSION PUMP |
Applicant |
DISETRONIC MEDICAL SYSTEMS AG |
5151 PROGRAM AVE. |
ST. PAUL,
MN
55112 -1014
|
|
Applicant Contact |
DAVID E CHADWICK |
Correspondent |
DISETRONIC MEDICAL SYSTEMS AG |
5151 PROGRAM AVE. |
ST. PAUL,
MN
55112 -1014
|
|
Correspondent Contact |
DAVID E CHADWICK |
Regulation Number | 880.5725
|
Classification Product Code |
|
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
|
|
|