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

    VECTORSURGE 5 MODEL 470

    K Number: K030648 · Decision Mar 28, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    17
    Review Days
    28

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    Basic Information

    Device Name
    VECTORSURGE 5 MODEL 470
    K Number
    K030648
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5850
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Metron Medical Australia, Pty, Ltd.
    Date Received
    February 28, 2003
    Decision Date
    March 28, 2003
    Product Code
    IPF
    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
    IPF Stimulator, Muscle, Powered

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    Other Clearances by Metron Medical Australia, Pty, Ltd.

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