Device Classification Name |
Stimulator, Nerve, Peripheral, Electric
|
510(k) Number |
K192958 |
Device Name |
TwitchView System |
Applicant |
Blink Device Company |
1530 Westlake Ave N Suite 600 |
Seattle,
WA
98109
|
|
Applicant Contact |
Justin Hulvershorn |
Correspondent |
Blink Device Company |
1530 Westlake Ave N Suite 600 |
Seattle,
WA
98109
|
|
Correspondent Contact |
Justin Hulvershorn |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 10/22/2019 |
Decision Date | 04/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|