Pill, Radio

Device Code: 1687

Product Code(s): EXW

Device Classification Information

Device Type ID1687
Device NamePill, Radio
Regulation DescriptionGastrointestinal Motility Monitoring System.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Gastroenterology Devices Branch (GEDB)
Submission Type510(k)
CFR Regulation Number876.1725 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeEXW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1687
DevicePill, Radio
Product CodeEXW
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionGastrointestinal Motility Monitoring System.
CFR Regulation Number876.1725 [🔎]
TPLC Last Update: 2019-04-02 19:57:48

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