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510(k) Data Aggregation

    K Number
    K012029
    Device Name
    REMEDY MODEL 2Z12
    Manufacturer
    APOLLO CORP.
    Date Cleared
    2001-12-31

    (186 days)

    Product Code
    KMG
    Regulation Number
    880.6710
    Why did this record match?
    Product Code :

    KMG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Apollo's Remedy® is intended for use as an optional accessory with Apollo whinpool bathing systems in which patients in healthcare facilities are bathed. This device is not intended to be sold as a separate, stand-alone device. The Remedy UV Water Purifier 2Z12 is a device that is intended for use only as an accessory on Apollo whirlpool bathing systems. The Apollo Remedy® is designed to reduce bacteria levels in bath water during the bathing cycle.
    Device Description
    Apollo's Remedy® is a device designed to kill bacteria in water that is used to bathe patients in health care facilities. The unit contains quartz tubes which house and isolate germicidal ultraviolet lights from the water in a disinfecting chamber. The Remedy® has no moving parts and is constructed of PVC piping, and the Remedy® is safe for users and the environment since no UV light is transmitted outside the disinfecting chamber. Sensors are provided in the device to signal that the ultraviolet lights are on. Apollo's Remedy® is intended for use only with Apollo whirlpool bathing systems in health care facilities where patients are bathed. Apollo's Remedy® is intended for use in killing bacteria bio-load in bath water. The Apollo Remedy® consists of a disinfecting chamber housing two ultraviolet bulbs at power and wattage levels known to destroy various microorganisms at specific exposure times.
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