Device Classification Name |
parathyroid autofluorescence detection device
|
De Novo Number |
DEN170056 |
Device Name |
Parathyroid Detection (Model PTeye) System |
Requester |
aibiomed, corp. |
107 west gutierrez sreet |
santa barbara,
CA
93101
|
|
Contact |
al memmolo |
|
Regulation Number | 878.4550
|
Classification Product Code |
|
Date Received | 09/25/2017 |
Decision Date | 11/02/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
General & Plastic Surgery
|
Review Advisory Committee |
General & Plastic Surgery
|
Classification Order |
Classification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|