Atlas FDA

FIJ

1 FDA 510(k) clearances · Product code

FDA profile

Official device name
System, Dialysate Delivery, Recirculating, Single Pass
Device class
Class II (moderate risk)
Regulation
21 CFR 876.5820
Medical specialty
Gastroenterology, Urology
Flags
Life-sustaining
Sort:Newest firstOldest first

Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
DIALYSIS MACHINES DM-346 & 346-1 (K772163)Extracorporeal Medical Specialities, Inc.1977-11-28

Track FIJ automatically

Every clearance here is in the API, with alerts when new ones post.