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510(k) Data Aggregation

    K Number
    K001524
    Device Name
    FORMA SCIENTIFIC DIRECT HEAT INCUBATORS
    Manufacturer
    THERMOQUEST CORP.
    Date Cleared
    2000-07-12

    (57 days)

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

    THERMOQUEST CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K991408
    Device Name
    FORMA SCIENTIFIC UNIVERSAL WATER-JACKETED INCUBATOR
    Manufacturer
    THERMOQUEST CORP.
    Date Cleared
    1999-07-19

    (88 days)

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

    THERMOQUEST CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Forma Scientific Universal Water Jacketed Incubators are intended to be used to store, preserve and grow gametes and/or embryos at or near body temperature. The intended use of these incubators is to provide an environment with controlled temperature, CO2 and an elevated humidity, for the development of ova or embryos. Certain models also control O2 at suppressed levels.
    Device Description
    The Forma Scientific incubators are bench top, or floor standing units. They control carbon dioxide (CO2), temperature and provide elevated humidity. Certain models also control O2 at suppressed levels. Controlled parameters and alarm functions are microprocessor controlled. The volume of each chamber is approximately 6.5 cubic feet (184 liters).
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