Device Classification Name |
system, imaging, gastrointestinal, wireless, capsule
|
De Novo Number |
DEN010002 |
510(K) Number |
K010312
|
Device Name |
GIVEN DIAGNOSTIC IMAGING SYSTEM |
Requester |
given imaging ltd. |
117 ahuzah st. |
ra'ananna,
IL
43373
|
|
Contact |
shoshana friedman |
|
Regulation Number | 876.1300
|
Classification Product Code |
|
Date Received | 06/11/2001 |
Decision Date | 08/01/2001 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Gastroenterology/Urology
|
Review Advisory Committee |
Gastroenterology/Urology
|
Type |
Post-NSE
|
|
|