BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    EXONIX

    K Number: K984199 · Decision Feb 17, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23
    Same Product Code
    88
    Applicant Total
    10
    Review Days
    85

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    Basic Information

    Device Name
    EXONIX
    K Number
    K984199
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5300
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Fibra Sonics, Inc.
    Date Received
    November 24, 1998
    Decision Date
    February 17, 1999
    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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    Other Clearances by Fibra Sonics, Inc.

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    K983199 FIBRA SONICS ULTRASONIC SURGICAL ASPIRATOR SYSTEM, MODEL 1000 CONSOLE MODEL
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    K842024 ULTRASONIC LITHOTRIPTOR 300A
    K834453 PHACO FRAGMENTOR GT-1
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    K812909 HYGIENTIST; CYCLOSON I & II; RETROFIT
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