LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K070426
    Device Name
    SILHOUETTE, MODEL 1000.01
    Manufacturer
    ARANZ MEDICAL LIMITED
    Date Cleared
    2007-06-29

    (136 days)

    Product Code
    FXN
    Regulation Number
    878.4160
    Why did this record match?
    Applicant Name (Manufacturer) :

    ARANZ MEDICAL LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Silhouette is indicated for wound measurement and documentation and can be used on all external wound types.
    Device Description
    Silhouette consists of a camera connected to a PDA, for the measurement and tracking of wounds
    Ask a Question

    Page 1 of 1