BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇦🇺 Australia

    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100

    K Number: K011955 · Decision Jul 16, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    17
    Review Days
    24

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    Basic Information

    Device Name
    MODIFICATION TO:ACCUSONIC PLUS, MODEL AP-100
    K Number
    K011955
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metron Medical Australia, Pty, Ltd.
    Date Received
    June 22, 2001
    Decision Date
    July 16, 2001
    Product Code
    IMI
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

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

    Product Code Device Name
    IMI Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat

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