The following data is part of a premarket notification filed by Blink Device Company with the FDA for Twitchview System.
Device ID | K192958 |
510k Number | K192958 |
Device Name: | TwitchView System |
Classification | Stimulator, Nerve, Peripheral, Electric |
Applicant | Blink Device Company 1530 Westlake Ave N Suite 600 Seattle, WA 98109 |
Contact | Justin Hulvershorn |
Correspondent | Justin Hulvershorn Blink Device Company 1530 Westlake Ave N Suite 600 Seattle, WA 98109 |
Product Code | KOI |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-10-22 |
Decision Date | 2020-04-02 |