Chair, Dialysis, Unpowered, Without Scales

Device Code: 1851

Product Code(s): FIA

Device Classification Information

Device Type ID1851
Device NameChair, Dialysis, Unpowered, Without Scales
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 1 Medical Device
Product CodeFIA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1851
DeviceChair, Dialysis, Unpowered, Without Scales
Product CodeFIA
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionHemodialysis System And Accessories.
CFR Regulation Number876.5820 [🔎]
TPLC Last Update: 2019-04-02 20:00:43

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