EyeCTester
FDA 510(k) clearance K203594 · decided 2022-09-07
Clearance details
- K-number
- K203594
- Device name
- EyeCTester
- Applicant
- Neuro-Eye Diagnostic Systems, LLC
- Decision
- Substantially Equivalent
- Date received
- 2020-12-09
- Decision date
- 2022-09-07
- Days to decision
- 637 days
- Clearance type
- Traditional
- Product code
- QTW
- Device class
- 1
- Regulation number
- 886.1330
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.