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

    CAMLAB CRANIAL ORTHOSIS HELMET

    K Number: K081787 · Decision Jan 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    13
    Same Product Code
    22
    Applicant Total
    1
    Review Days
    217

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    Basic Information

    Device Name
    CAMLAB CRANIAL ORTHOSIS HELMET
    K Number
    K081787
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    882.5970
    Medical Specialty
    Neurology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biosculptor Corporation
    Date Received
    June 24, 2008
    Decision Date
    January 27, 2009
    Product Code
    OAN
    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
    OAN Orthosis, Cranial, Laser Scan

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