FEN
- Product code
- FEN
- Device name
- Device, Cystometric, Hydraulic
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.1620
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K) Exempt
- 510(k) clearances (all years, FDA)
- 36 (all years; only the last 3 years are listed here)
Official FDA classification page: FEN
Classification and pathway per current FDA publications. Data from openFDA (CC0).