System, Electrogastrography (egg)

Device Code: 2011

Product Code(s): MYE

Device Classification Information

Device Type ID2011
Device NameSystem, Electrogastrography (egg)
Regulation DescriptionElectrogastrography System.
Regulation Medical SpecialtyGastroenterology/Urology
Review PanelGastroenterology/Urology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(k)
CFR Regulation Number876.1735 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeMYE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2011
DeviceSystem, Electrogastrography (egg)
Product CodeMYE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionElectrogastrography System.
CFR Regulation Number876.1735 [🔎]
TPLC Last Update: 2019-04-02 20:04:08

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