Device Classification Name |
cranial electrotherapy stimulator to treat depression
|
510(k) Number |
K182311 |
Device Name |
Cervella |
Applicant |
Innovative Neurological Devices LLC |
13295 Illinois St, Suite 312 |
carmel,
IN
46032
|
|
Applicant Contact |
bart waclawik |
Correspondent |
Innovative Neurological Devices LLC |
13295 Illinois St, Suite 312 |
carmel,
IN
46032
|
|
Correspondent Contact |
bart waclawik |
Regulation Number | 882.5800
|
Classification Product Code |
|
Date Received | 08/24/2018 |
Decision Date | 03/07/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|