510(k) K191700
K191700 is an FDA 510(k) premarket notification submitted by Blinktbi, Inc. for the device "EyeStat". The FDA issued a decision of Substantially Equivalent on December 9, 2019. The device falls under product code GZP (Stimulator, Mechanical, Evoked Response), a Class II device regulated under 21 CFR 882.1880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 9, 2019
- Date Received
- June 25, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Mechanical, Evoked Response
- Device Class
- Class II
- Regulation Number
- 882.1880
- Review Panel
- NE
- Submission Type