DEN230043
- 510(k) number
- DEN230043
- Device name
- Notal Vision Home Optical Coherence Tomography (OCT) System
- Applicant
- Notal Vision, Inc. VA · US
- Product code
- SAX — Home Monitoring Ophthalmic Optical Coherence Tomogra
- Decision date
- 2024-05-15
- Date received
- 2023-06-07
- Decision
- Unknown
- Clearance type
- Direct
- Advisory committee
- Ophthalmic
Official FDA record: DEN230043
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.