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

    BALLERT CRANIAL MOLDING HELMET

    K Number: K011433 · Decision Jun 12, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16
    Same Product Code
    42
    Applicant Total
    1
    Review Days
    33

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    Basic Information

    Device Name
    BALLERT CRANIAL MOLDING HELMET
    K Number
    K011433
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Gema, Inc.
    Date Received
    May 10, 2001
    Decision Date
    June 12, 2001
    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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