BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gastric Emptying Breath Test

    PMA: P110015 · Supplement: S009 · Decision May 19, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2

    Basic Information

    Device Name
    Gastric Emptying Breath Test
    Trade Name
    13C-Spirulina Gastric Emptying Breath Test (GEBT)
    PMA Number
    P110015
    Supplement Number
    S009
    Device Class
    FDA Class 3
    Product Code
    PGE
    Generic Name
    Gastric Emptying Breath Test
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 19, 2023
    Date Received
    October 20, 2021
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of an updated model of Gas Isotope Ratio Mass Spectrometer (GIRMS) for use in analyzing 13C/12C ratios in breath samples as part of your approved 13C-Spirulina Gastric Emptying Breath Test (GEBT)

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PGE Gastric Emptying Breath Test