510(k) K192958
K192958 is an FDA 510(k) premarket notification submitted by Blink Device Company for the device "TwitchView System". The FDA issued a decision of Substantially Equivalent on April 2, 2020. The device falls under product code KOI (Stimulator, Nerve, Peripheral, Electric), a Class II device regulated under 21 CFR 868.2775.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 2, 2020
- Date Received
- October 22, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Peripheral, Electric
- Device Class
- Class II
- Regulation Number
- 868.2775
- Review Panel
- AN
- Submission Type