FLAClass IILife-sustaining
Monitor, Temperature, Dialysis
Gastroenterology, Urology · 21 CFR 876.5820
MDR events1All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances3All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
3 clearances for this product code