TwitchView System

Stimulator, Nerve, Peripheral, Electric

Blink Device Company

The following data is part of a premarket notification filed by Blink Device Company with the FDA for Twitchview System.

Pre-market Notification Details

Device IDK192958
510k NumberK192958
Device Name:TwitchView System
ClassificationStimulator, Nerve, Peripheral, Electric
Applicant Blink Device Company 1530 Westlake Ave N Suite 600 Seattle,  WA  98109
ContactJustin Hulvershorn
CorrespondentJustin Hulvershorn
Blink Device Company 1530 Westlake Ave N Suite 600 Seattle,  WA  98109
Product CodeKOI  
CFR Regulation Number868.2775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-22
Decision Date2020-04-02

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