Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K021725 |
Device Name |
DISETRONIC D-TRON INSULIN INFUSION PUMP |
Applicant |
DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERSTRASSE 190, POSTFACH |
BURGDORF,
CH
CH-3401
|
|
Applicant Contact |
SANDRA SONIEC |
Correspondent |
DISETRONIC MEDICAL SYSTEMS AG |
KIRCHBERSTRASSE 190, POSTFACH |
BURGDORF,
CH
CH-3401
|
|
Correspondent Contact |
SANDRA SONIEC |
Regulation Number | 880.5725
|
Classification Product Code |
|
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
|
|
|