ESE
- Product code
- ESE
- Device name
- Larynx, Artificial (Battery-Powered)
- Device class
- Class 1
- 21 CFR
- 21 CFR 874.3375
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (last 3 years)
- 13
Official FDA classification page: ESE
Classification and pathway per current FDA publications. Data from openFDA (CC0).