Table, Cystometric, Non-electric And Accessories

Device Code: 1979

Product Code(s): KQS

Device Classification Information

Device Type ID1979
Device NameTable, Cystometric, Non-electric And Accessories
Regulation DescriptionUrological Table 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 Number876.4890 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeKQS
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1979
DeviceTable, Cystometric, Non-electric And Accessories
Product CodeKQS
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionUrological Table And Accessories.
CFR Regulation Number876.4890 [🔎]
TPLC Last Update: 2019-04-02 20:03:17

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