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510(k) Data Aggregation

    K Number
    K970482
    Device Name
    TRANSCOM COLON HYDROTHERAPY MODEL HC-2000
    Manufacturer
    SRS INTL.
    Date Cleared
    1997-10-31

    (263 days)

    Product Code
    KPL
    Regulation Number
    876.5220
    Why did this record match?
    Applicant Name (Manufacturer) :

    SRS INTL.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The indication for use of this device must be restricted to colon cleansing when medically indicated, such as before radiological or endoscopic examination.
    Device Description
    This device is not a kit. This device is an instrument for hydrotherapy of the colon. It introduces filtered water at a confortable temperature into the large intestine. It is an automatic system for filling and emptying water into and out of the colon and thus cleansing the colon of its contents when medically indicated such as before radiological or endoscopic examination. It is hygienic, painless and odorless. The instrument has an automatic pressure safety system; automatic disinfection; a system for collection of samples for analysis; remote and frontal panel control; a counter for the number of liters of water used; a three-way faucet; flow regulator; thermostatic mixer and an automatic temperature safety feature. It contains disposable components for use only once in the therapy
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