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510(k) Data Aggregation

    K Number
    K142303
    Device Name
    NeumoFilt Ergo/Neumo Filt BiteOn
    Date Cleared
    2014-11-20

    (94 days)

    Product Code
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    Medical Respiratory Devices S.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For use with pulmonary function testing (PFT) equipment only, to filter air between the patient's exhaled air and the testing equipment. Single patient use, disposable. Duraton of use < 24 hours. Environment of use: Hospital, Sub-acute facilities, Clinics, Physician offices.
    Device Description
    The MRD NeumoFilt pulmonary function filter ("PFT filter") is a standard electrostatic filter that is placed between the patient and the pulmonary function testing equipment to keep a patient inhaled and exhaled breath from contaminating the equipment. There are 2 models with the only difference being the patient end piece which is either a biteblock shape (BiteOn) or the mouthpiece shape (Ergo).
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