BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    SoftSpot

    K Number: K212045 · Decision Sep 28, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    0
    Applicant Total
    1
    Review Days
    90

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    Basic Information

    Device Name
    SoftSpot
    K Number
    K212045
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4800
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Pediametrix, Inc.
    Date Received
    June 30, 2021
    Decision Date
    September 28, 2021
    Product Code
    QQO
    Advisory Committee
    General, Plastic Surgery
    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
    QQO Cranial Measurement Software