BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    Parallel

    K Number: DEN200029 · Decision Nov 25, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    209

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    Basic Information

    Device Name
    Parallel
    K Number
    DEN200029
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    876.5960
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Unknown
    Applicant
    Mahana Therapeutics, Inc.
    Date Received
    April 30, 2020
    Decision Date
    November 25, 2020
    Product Code
    QMY
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QMY Computerized Behavioral Therapy Device For Treating Symptoms

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    Other Clearances by Mahana Therapeutics, Inc.

    K Number Device Name
    K211372 Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)