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510(k) Data Aggregation

    K Number
    K021042
    Device Name
    THERMO FORMA, CRYOMED, CONTROLLED RATE FREEZERS; MODELS # 7456, 7457, 7458,7459,7475,7476
    Manufacturer
    THERMO FORMA, INC.
    Date Cleared
    2002-05-15

    (44 days)

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

    THERMO FORMA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Thermo Forma CryoMed ® Controlled Rate Freezers are intended to be used to freeze gametes and/or embryos at a user determined rate. This device is not intended for long-term storage. The intended use of these freezers is to freeze gametes and/or embryos. The freezer is designed to allow the user to select the desired cooling rate and temperature, for the purpose of improved viability.
    Device Description
    The CryoMed controlled rate freezers are bench top units. They control temperature and temperature rate through the use of liquid nitrogen (LN2), an electric heater and an air-circulating fan. Freezing parameters and alarm functions are controlled by a microprocessor built into the controlled rate freezer itself. The freezer is supplied with several preloaded freezing profiles as well as allowing the user to define their own profiles. Optional PC resident software, supplied with each unit, allows user defined programs to be written on a personal computer and downloaded to the freezer. The freezer then stores these parameters in its memory and takes over control of the run.
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