Device Classification Name |
pump, infusion, insulin
|
510(k) Number |
K082595 |
Device Name |
MODIFICATION TO:ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE |
Applicant |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Applicant Contact |
Scott Thiel |
Correspondent |
Roche Diagnostics |
9115 Hague Road |
Indianapolis,
IN
46250
|
|
Correspondent Contact |
Scott Thiel |
Regulation Number | 880.5725
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 09/08/2008 |
Decision Date | 10/28/2008 |
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
|
|
|