Set, Dialyzer Holder

Device Code: 1900

Product Code(s): FKI

Device Classification Information

Device Type ID1900
Device NameSet, Dialyzer Holder
Regulation DescriptionHemodialysis System And Accessories.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission Type510(K) Exempt
CFR Regulation Number876.5820 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFKI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1900
DeviceSet, Dialyzer Holder
Product CodeFKI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHemodialysis System And Accessories.
CFR Regulation Number876.5820 [🔎]
TPLC Last Update: 2019-04-02 20:01:39

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.