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

    Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)

    K Number: K211372 · Decision Jun 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    2
    Applicant Total
    2
    Review Days
    29

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    Basic Information

    Device Name
    Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
    K Number
    K211372
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    876.5960
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Mahana Therapeutics, Inc.
    Date Received
    May 4, 2021
    Decision Date
    June 2, 2021
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QMY), ordered by most recent decision date.

    Regulora

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Parallel

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology
    View all

    Other Clearances by Mahana Therapeutics, Inc.

    K Number Device Name
    DEN200029 Parallel