510(k) K203594
K203594 is an FDA 510(k) premarket notification submitted by Neuro-Eye Diagnostic Systems, LLC for the device "EyeCTester". The FDA issued a decision of Substantially Equivalent on September 7, 2022. The device falls under product code QTW (Digital Amsler Grid), a Class I device regulated under 21 CFR 886.1330.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 2022
- Date Received
- December 9, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Amsler Grid
- Device Class
- Class I
- Regulation Number
- 886.1330
- Review Panel
- OP
- Submission Type
A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.