DeviceClearance

Product code FJB— Gastroenterology, Urology

ACCUFLO UF CONTROL MODULE NO. 74-0100-3

Classification name
Detector, Dialysate Level
Device class
Class 2
Regulation
21 CFR 876.5820
Advisory panel
Gastroenterology, Urology
Total cleared
3
First cleared
Most recent

Market context for product code FJB

FDA has cleared 3 devices under product code FJB, all in 1988, filed by 3 applicant companies. 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 FJB

Recent clearances under product code FJB

Data sourced from openFDA. This site is unofficial and independent of the FDA.