Device Classification Name |
calculator, drug dose
|
510(k) Number |
K082512 |
Device Name |
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER |
Applicant |
DIMENSIONAL DOSING SYSTEMS, INC. |
1468 HARWELL AVE |
CROFTON,
MD
21114
|
|
Applicant Contact |
EJ Smith |
Correspondent |
DIMENSIONAL DOSING SYSTEMS, INC. |
1468 HARWELL AVE |
CROFTON,
MD
21114
|
|
Correspondent Contact |
EJ Smith |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 08/29/2008 |
Decision Date | 11/07/2008 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|