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

    PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0

    K Number: K130165 · Decision Aug 30, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    26
    Registration Numbers
    26
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    219

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    Basic Information

    Device Name
    PICTZAR DIGITAL PLANIMETRY SOFTWARE APPLICATION 7.0
    K Number
    K130165
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.4160
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Advanced Planimetric Services, LLC
    Date Received
    January 23, 2013
    Decision Date
    August 30, 2013
    Product Code
    FXN
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    FXN Tape, Camera, Surgical

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