Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K032164 |
Device Name |
DIABETES DATA MANAGEMENT SYSTEM (DDMS), MODEL 7333 |
Applicant |
MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. |
NORTHRIDGE,
CA
91325 -1219
|
|
Applicant Contact |
GERDA P RESCH |
Correspondent |
MEDTRONIC MINIMED |
18000 DEVONSHIRE ST. |
NORTHRIDGE,
CA
91325 -1219
|
|
Correspondent Contact |
GERDA P RESCH |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 07/15/2003 |
Decision Date | 10/23/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|