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De Novo DEN230043
- Device
- Notal Vision Home Optical Coherence Tomography (OCT) System
- Contact
- kester nahen
- De Novo number
- DEN230043
- Product code
- SAX
- Regulation
- 886.1600
- Classification name
- home monitoring ophthalmic optical coherence tomography (oct) imaging device
- Decision
- granted (DENG)
- Decision date
- 2024-05-15
- Date received
- 2023-06-07
- Classification advisory
- Ophthalmic
- Review advisory
- Ophthalmic
- Type
- Direct
Current FDA Classification#
- Product code
- SAX
- Device name
- Home Monitoring Ophthalmic Optical Coherence Tomography (Oct) Imaging Device
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation
- 886.1600
- Implant
- N
- Life sustain/support
- N