BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇹 Italy

    SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2

    K Number: K083780 · Decision Mar 23, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    38
    Applicant Total
    2
    Review Days
    94

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    Basic Information

    Device Name
    SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2
    K Number
    K083780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    874.3495
    Medical Specialty
    Ear, Nose, Throat
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Audio Technologies S.R.L.
    Date Received
    December 19, 2008
    Decision Date
    March 23, 2009
    Product Code
    ETA
    Advisory Committee
    Ear, Nose, Throat
    Review Advisory Committee
    EN
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ETA Replacement, Ossicular Prosthesis, Total

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    Other Clearances by Audio Technologies S.R.L.

    K Number Device Name
    K001142 AUDIO TECHNOLOGIES S:R.1