Device Classification Name |
stimulator, nerve, peripheral, electric
|
510(k) Number |
K172843 |
Device Name |
TwitchView System |
Applicant |
Blink Device Corporation |
1530 Westlake Ave N Suite 600 |
Seattle,
WA
98109
|
|
Applicant Contact |
Justin Hulvershorn |
Correspondent |
Blink Device Corporation |
1530 Westlake Ave N Suite 600 |
Seattle,
WA
98109
|
|
Correspondent Contact |
Justin Hulvershorn |
Regulation Number | 868.2775
|
Classification Product Code |
|
Date Received | 09/19/2017 |
Decision Date | 03/29/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|