EyeStat— 510(k) K191700
Substantially EquivalentBlinktbi, Inc.
FDA 510(k) clearance K191700 for EyeStat, Substantially Equivalent on 2019-12-09. Applicant: Blinktbi, Inc.. Device class: 2.
Clearance details
- Applicant
- Blinktbi, Inc.
- Product code
- Code GZP
- Device class
- Class 2
- Regulation
- 21 CFR 882.1880
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Charleston, SC, US
Recent devices under product code GZP
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