HJI
- Product code
- HJI
- Device name
- Lens, Fundus, Hruby, Diagnostic
- Device class
- Class 1
- 21 CFR
- 21 CFR 886.1395
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K) Exempt
- Flag
- GMP exempt
- 510(k) clearances (last 3 years)
- 8
Official FDA classification page: HJI
Classification and pathway per current FDA publications. Data from openFDA (CC0).