BEUDAMED
    Product Code: PGE FDA class 3

    Gastric Emptying Breath Test

    Unknown

    The Gastric Emptying Breath Test is a diagnostic test system intended for measuring the rate of gastric emptying of solids and aiding in the diagnosis of delayed gastric emptying (gastroparesis) in symptomatic adult patients. The system typically uses a mass spectrometer to measure the ratio of 13CO2 to 12CO2 in breath samples following ingestion of a 13C-labeled test meal. It is an FDA Class 3 device, requiring Pre-Market Approval (PMA), reviewed by the Toxicology (TX) panel with no assigned regulation number or medical specialty. The product code is PGE.

    View on FDA
    510(k)s
    0
    FEI Numbers
    2
    Registration Numbers
    2
    Unique Applicants
    0
    Years Active
    —

    Basic Information

    Product Code
    PGE
    Device Class
    FDA class 3
    Medical Specialty
    Unknown
    Review Panel
    TX
    Submission Type
    2

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Gastric emptying breath tests are intended for use in the measurement of the rate of gastric emptying of solids and as an aid in the diagnosis of delayed gastric emptying (gastroparesis) in adult humans who are symptomatic for gastoparesis.The test system typically utilizes a Mass Spectrometer for the measurement of the ratio of 13CO2 to 12CO2 in breath samples following the ingestion of a 13C-labeled test meal.

    FEI Numbers

    This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.