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510(k) Data Aggregation

    K Number
    K023465
    Device Name
    KENDRO HERACELL 240 INCUBATOR
    Date Cleared
    2003-03-10

    (146 days)

    Product Code
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENDRO LABORATORY PRODUCTS, L.P.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The intended use of this incubator is to provide an environment with controlled temperature, CO2 elevated humidity, an automatic decontamination mode, and O2 at suppressed levels, for the development of ova or embryos at or near body temperature.
    Device Description
    The Kendro HERAcell 240 incubators are bench top or floor standing units. The devices control CO2, temperature, provide elevated humidity, feature a decontamination mode, and control O- at suppressed levels to ensure the proper development of ova or embryos at or near body temperature. The conditions produced by the subject device are an exact simulation of physiological conditions. Controlled parameters and alarin functions are microprocessor controlled. The basic model includes the auto-zero self-balancing CO2 control system, which ensures long term stability of CO2 levels. Each unit is equipped with a water level alarm to remind the user to refill the water reservoir. As with the predicate device the user has the choice of a stainless steel or solid copper inner chamber. Additionally, the user can choose from additional options such as Oxygen control, Infra-Red Sensor, and the roller bottle system. The basic model includes the TC (thermal conductivity) sensor, however the user can choose the Infra-Red Sensor option.
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    K Number
    K002805
    Device Name
    KENDRO HERACELL CO2 INCUBATOR
    Date Cleared
    2000-11-09

    (62 days)

    Product Code
    Regulation Number
    884.6120
    Why did this record match?
    Applicant Name (Manufacturer) :

    KENDRO LABORATORY PRODUCTS, L.P.

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