Notal Vision Home Optical Coherence Tomography (OCT) System
FDA 510(k) clearance DEN230043 · decided 2024-05-15
Clearance details
- K-number
- DEN230043
- Device name
- Notal Vision Home Optical Coherence Tomography (OCT) System
- Applicant
- Notal Vision, Inc.
- Decision
- Unknown
- Date received
- 2023-06-07
- Decision date
- 2024-05-15
- Days to decision
- 343 days
- Clearance type
- Direct
- Product code
- SAX
- Device class
- 2
- Regulation number
- 886.1600
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Manassas, VA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.