Detector, Leak, Blood

Device Code: 1872

Product Code(s): FJD

Device Classification Information

Device Type ID1872
Device NameDetector, Leak, Blood
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)
CFR Regulation Number876.5820 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeFJD
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1872
DeviceDetector, Leak, Blood
Product CodeFJD
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHemodialysis System And Accessories.
CFR Regulation Number876.5820 [🔎]
TPLC Last Update: 2019-04-02 20:01:06

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