ETW
- Product code
- ETW
- Device name
- Calibrator, Hearing Aid / Earphone And Analysis Systems
- Device class
- Class 2
- 21 CFR
- 21 CFR 874.3310
- Medical specialty
- Ear, Nose, Throat
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 46 (all years; only the last 3 years are listed here)
Official FDA classification page: ETW
Classification and pathway per current FDA publications. Data from openFDA (CC0).