Device Classification Name |
external upper limb tremor stimulator
|
De Novo Number |
DEN170028 |
Device Name |
Cala ONE |
Requester |
Cala Health, Inc. |
875 mahler road. |
suite 168 |
burlingame,
CA
94010
|
|
Contact |
scott a. wilson |
|
Regulation Number | 882.5897
|
Classification Product Code |
|
Date Received | 05/17/2017 |
Decision Date | 04/26/2018 |
Decision |
granted
(DENG) |
Classification Advisory Committee |
Neurology
|
Review Advisory Committee |
Neurology
|
Reclassification Order |
Reclassification Order
|
FDA Review |
Decision Summary
|
Type |
Direct
|
|
|