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510(k) Data Aggregation

    K Number
    K993092
    Device Name
    SONADA ULTRASOUND SYSTEM
    Manufacturer
    SONOVISION CORP.
    Date Cleared
    2000-04-14

    (211 days)

    Product Code
    OXO
    Regulation Number
    892.1650
    Why did this record match?
    Applicant Name (Manufacturer) :

    SONOVISION CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal, Small Organ, Transrectal, Transvaginal, Peripheral Vascular. CLI 4900 6.5MHz Trans-vaginal (endocavity) probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transvaginal. CLI 5000 6.5MHz Trans-rectal (endocavity) probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Transrectal. CLI 6000 12.5MHz Peripheral Vascular probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Small Organ, Peripheral Vascular. CLI 7900 3.5MHz General Abdominal probe: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Abdominal.
    Device Description
    Not Found
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