Product code FIJ— Gastroenterology, Urology
DIALYSIS MACHINES DM-346 & 346-1
- Classification name
- System, Dialysate Delivery, Recirculating, Single Pass
- Device class
- Class 2
- Regulation
- 21 CFR 876.5820
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code FIJ
FDA has cleared device under product code FIJ, all in 1977, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code FIJ
Recent clearances under product code FIJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.