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

    VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460

    K Number: K003260 · Decision Feb 22, 2001
    View on FDA
    Classifications
    1
    FEI Numbers
    170
    Registration Numbers
    170
    Same Product Code
    547
    Applicant Total
    17
    Review Days
    127

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    Basic Information

    Device Name
    VECTORSURGE 4 INTERFERENTIAL THERAPY UNIT MODEL VS 460
    K Number
    K003260
    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
    October 18, 2000
    Decision Date
    February 22, 2001
    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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