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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
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MOBLVAC W.C.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but based on the provided text, I cannot provide a description of the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for a device called "MOBLVAC W.C." which is a powered suction pump.

    The letter grants clearance based on substantial equivalence to a predicate device, but it does not contain information about:

    • Specific acceptance criteria for performance (e.g., specific thresholds for suction pressure, flow rate, or durability).
    • Study details that would prove the device meets such criteria (e.g., sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance).

    The letter confirms the device's classification, regulatory requirements, and its stated "Indications for Use" but does not delve into the technical testing or studies conducted to establish its performance.

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