510(k) DEN230043
- Device
- Notal Vision Home Optical Coherence Tomography (OCT) System
- Applicant
- Notal Vision, Inc.
- 510(k) number
- DEN230043
- Product code
- SAX
- Decision
- Unknown (DENG)
- Decision date
- 2024-05-15
- Date received
- 2023-06-07
- Regulation
- 886.1600
- Classification name
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kester Nahen
- Address
- 7717 Coppermine Dr. Manassas VA US 20109 20109
FDA Registration Numbers#
- 3004103096
- 3008364787
Source Documents#
510(k) summary PDF not indicated by FDA