Detector, Air Bubble

Device Code: 1873

Product Code(s): FJF

Device Classification Information

Device Type ID1873
Device NameDetector, Air Bubble
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 CodeFJF
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceYes
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1873
DeviceDetector, Air Bubble
Product CodeFJF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionHemodialysis System And Accessories.
CFR Regulation Number876.5820 [🔎]
TPLC Last Update: 2019-04-02 20:01:08

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