Device Classification Name |
continuous glucose monitor secondary display
|
De Novo Number |
DEN140038 |
Device Name |
Dexcom Share Direct Secondary Displays |
Requester |
dexcom, inc. |
6340 sequence drive |
san diego,
CA
92121
|
|
Contact |
andrew k balo |
|
Regulation Number | 862.1350
|
Classification Product Code |
|
Date Received | 12/15/2014 |
Decision Date | 01/23/2015 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Clinical Chemistry
|
Review Advisory Committee |
Clinical Chemistry
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|