FIB
- Product code
- FIB
- Device name
- Protector, Transducer, Dialysis
- Device class
- Class 2
- 21 CFR
- 21 CFR 876.5820
- Medical specialty
- Gastroenterology, Urology
- Marketing pathway
- 510(K)
- Flag
- Life-sustaining / life-supporting
- 510(k) clearances (last 3 years)
- 35
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K240164 | 2024-06-28 | Bain Medical Equipment (Guangzhou) Co. | NovaLine SP-C35 Transducer Protector (956007) |
Official FDA classification page: FIB
Classification and pathway per current FDA publications. Data from openFDA (CC0).