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510(k) Data Aggregation

    K Number
    K983052
    Device Name
    PERITRON PERINEOMETER MODEL 9300V OR 9300A
    Manufacturer
    CARDIO DESIGN PTY. LTD.
    Date Cleared
    1998-10-19

    (48 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO DESIGN PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Peritron is used in assessing the strength of pelvic floor muscles, teaching pelvic floor muscle exercises and for providing feedback during pelvic floor muscles exercises.
    Device Description
    The Peritron Perineometer comprises a vaginal or anal Sensor, Readout Unit and interconnecting tube. Peritron incorporates a pressure transducer and microprocessor to interpret the air pressure in the sensor and display it either numerically in cm water column pressure or as an analogue bar graph. Hand-held Peritron weighs 220 gm and is powered by a standard 9 volt battery housed in an integral, user-accessible compartment separated physically from the electronic components. All operating functions are controlled by one push-button. The case of Peritron is of injection moulded plastic.
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    K Number
    K945611
    Device Name
    PERITRON
    Manufacturer
    CARDIO DESIGN PTY. LTD.
    Date Cleared
    1996-02-08

    (450 days)

    Product Code
    HIR
    Regulation Number
    884.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARDIO DESIGN PTY. LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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