Clearance Summary
TwitchView System received FDA 510(k) clearance under submission number K172843, sponsored by Blink Device Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Anesthesiology review panel. The statutory decision date of record is 2018-03-29.
- Submission: K172843
- Applicant / Sponsor: Blink Device Corporation
- Clearance pathway: Traditional
- Review panel: Anesthesiology
- Device class: Class II
- Regulation citation: 21 CFR 868.2775
- Decision date: 2018-03-29
Classification & Regulation
This clearance is catalogued under FDA product code KOI and 21 CFR 868.2775, within the Anesthesiology review panel as a Class II device.