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

    Cognoa ASD Diagnosis Aid

    K Number: DEN200069 · Decision Jun 2, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    5
    Applicant Total
    2
    Review Days
    211

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    Basic Information

    Device Name
    Cognoa ASD Diagnosis Aid
    K Number
    DEN200069
    Device Class
    FDA class 2
    Clearance Type
    Direct
    Regulation Number
    882.1491
    Medical Specialty
    Neurology
    Decision
    Unknown
    Applicant
    Cognoa, Inc.
    Date Received
    November 3, 2020
    Decision Date
    June 2, 2021
    Product Code
    QPF
    Advisory Committee
    Neurology
    Review Advisory Committee
    NE
    Third Party
    N

    Classifications

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

    Product Code Device Name
    QPF Pediatric Autism Spectrum Disorder Diagnosis Aid

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