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

    ORTHOSIS HELMET MOLDING

    K Number: K013700 · Decision Feb 5, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    89

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    Basic Information

    Device Name
    ORTHOSIS HELMET MOLDING
    K Number
    K013700
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Precision Prosthetics & Orthotics, Inc.
    Date Received
    November 8, 2001
    Decision Date
    February 5, 2002
    Product Code
    MVA
    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
    MVA Orthosis, Cranial

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