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510(k) Data Aggregation

    K Number
    K081185
    Device Name
    MOBLVAC W.C.
    Manufacturer
    OHIO MEDICAL CORPORATION
    Date Cleared
    2008-05-02

    (7 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    OHIO MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the MOBLVAC W.C. is as an aspirator to be used to help evacuate saliva, mucous, vomit or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient and also as a pleural and wound drainage device.
    Device Description
    The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient.
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    K Number
    K062610
    Device Name
    CARE-E-VAC 3
    Manufacturer
    OHIO MEDICAL CORPORATION
    Date Cleared
    2006-09-28

    (23 days)

    Product Code
    BTA
    Regulation Number
    878.4780
    Why did this record match?
    Applicant Name (Manufacturer) :

    OHIO MEDICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The device is a portable aspirator which uses suction as a means to withdraw fluids or foreign bodies from a patient. The primary intended use of the care-e-vac 3 is as an aspirator to be used to help evacuate saliva, mucous, vomitous or other aspirant from the mouth and or airway to allow adequate respiration or ventilation of the patient.
    Device Description
    The device uses conventional technology to provide medical suction. The mechanical portion of the aspirator consists of an electrically driven pump to provide suction, a gauge to indicate the suction level and a regulator to control the suction level.
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