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    K Number
    K050183
    Device Name
    SILFAB SUPER 2 MAX COMPRESSOR, N28 SERIES
    Manufacturer
    SILVESTRIN FABRIS S.R.L.
    Date Cleared
    2005-08-16

    (201 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    SILVESTRIN FABRIS S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient. The device can be used with adult or pediatric patients suffering from respiratory disorders such as asthma, allergies, etc
    Device Description
    The SILFAB model Super 2 Max N28 Compressor / Nebulizer is an ACpowered air compressor that provides compressed air for home health care use. This device is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol for inhalation by a patient.
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