| Device Classification Name |
pump, infusion, insulin
|
|---|
| 510(k) Number |
K022831 |
|---|
| Device Name |
MODIFICATION TO DISETRONIC D-TRONPLUS INSULIN INFUSION PUMP |
|---|
| Applicant |
| DISETRONIC MEDICAL SYSTEMS AG |
| KIRCHBERSTRASSE 190, POSTFACH |
|
BURGDORF,
SE
CH-3401
|
|
| Applicant Contact |
SANDRA SONIEC |
| Correspondent |
| DISETRONIC MEDICAL SYSTEMS AG |
| KIRCHBERSTRASSE 190, POSTFACH |
|
BURGDORF,
SE
CH-3401
|
|
| Correspondent Contact |
SANDRA SONIEC |
| Regulation Number | 880.5725
|
|---|
| Classification Product Code |
|
|---|
| 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
|
|---|