BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Gastric Emptying Breath Test

    PMA: P110015 · Supplement: S008 · Decision Aug 10, 2021
    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
    S008
    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
    August 10, 2021
    Date Received
    March 16, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a change to labeling that will facilitate telehealth administration of the device.

    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