HKM
- Product code
- HKM
- Device name
- Retinoscope, Battery-Powered
- Device class
- Class 1
- 21 CFR
- 21 CFR 886.1780
- Medical specialty
- Ophthalmic
- Marketing pathway
- 510(K) Exempt
- Flag
- GMP exempt
- 510(k) clearances (all years, FDA)
- 7 (all years; only the last 3 years are listed here)
Official FDA classification page: HKM
Classification and pathway per current FDA publications. Data from openFDA (CC0).