Device Classification Name |
Accessories, Pump, Infusion
|
510(k) Number |
K112370 |
Device Name |
WELLDOC DIABETES MANAGER SYSTEM AND DIABETES MANAGER RX SYSTEM |
Applicant |
WELLDOC, INC |
1501 SAINT PAUL STREET |
SUITE 118 |
BALTIMORE,
MD
21202
|
|
Applicant Contact |
LAUREN BRONICH-HALL |
Correspondent |
WELLDOC, INC |
1501 SAINT PAUL STREET |
SUITE 118 |
BALTIMORE,
MD
21202
|
|
Correspondent Contact |
LAUREN BRONICH-HALL |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 08/17/2011 |
Decision Date | 10/14/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|