Device Classification Name |
medical device data system
|
510(k) Number |
K122361 |
Device Name |
T:CONNECT DATA MANAGEMENT SYSTEM |
Applicant |
TANDEM DIABETES CARE, INC. |
11045 Roselle St Ste 200 |
san diego,
CA
92121
|
|
Applicant Contact |
don canal |
Correspondent |
TANDEM DIABETES CARE, INC. |
11045 Roselle St Ste 200 |
san diego,
CA
92121
|
|
Correspondent Contact |
don canal |
Regulation Number | 880.6310
|
Classification Product Code |
|
Date Received | 08/03/2012 |
Decision Date | 02/22/2013 |
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
|
|
|