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510(k) Data Aggregation

    K Number
    K041974
    Device Name
    MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER
    Manufacturer
    MED2000 S.R.L.
    Date Cleared
    2004-08-24

    (33 days)

    Product Code
    BTI
    Regulation Number
    868.6250
    Why did this record match?
    Applicant Name (Manufacturer) :

    MED2000 S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED2000 SpA Nebulizer Compressors, Models P3, P4 and P5, with Nebulizer, are ACpowered air compressors intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis, COPD, etc. It can be used with adult or pediatric patients.
    Device Description
    These line powered piston compressors are housed in a plastic cabinet (case). The plastic cabinet is the only distinctive component between the three devices, that are identical for all other components, material and characteristics. Dimensions are 4.7 in. x 9.1 x 7.5 in. and weight 3.3 lbs. P3, P4 and P5 units contain no microprocessors or other electronic components. They operate from 115 VAC, 60 Hz. Each unit is supplied with an instruction manual and an accessory kit containing a nebulizer pediatric mask, a mouthpiece.
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    K Number
    K041327
    Device Name
    MED2000 SPA NEBULIZER ANDYFLOW, MODEL A1/C WITH ACCESSORIES
    Manufacturer
    MED2000 S.R.L.
    Date Cleared
    2004-07-20

    (63 days)

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

    MED2000 S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients. The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, may be used with compatible compressors or an air gas source providing between 4 and 8 lpm.
    Device Description
    The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use. The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices.
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    K Number
    K031908
    Device Name
    MED2000 SPA NEBULIZER COMPRESSORS, MODELS P1 AND P2, WITH NEBULIZER, AND MED2000 SPA NEBULIZER, MODEL A1/C (ANDYFLOW)
    Manufacturer
    MED2000 S.R.L.
    Date Cleared
    2004-01-14

    (208 days)

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

    MED2000 S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Med2000 SpA Nebulizer Compressors, Models P1 and P2, are AC-powered air compressors, with adapter, intended to provide a source of compressed air for medical purposes for use in home health care. These devices are provided with the Model A1/C (AndyFlow) pneumatic nebulizer and should only be used with this nebulizer to produce a fine aerosol mist of medication for respiratory therapy, for inhalation by a patient for treatment of respiratory disorders such as allergies, asthma, cystic fibrosis. COPD. etc. It can be used with adult or pediatric patients. The Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories, is a pneumatic nebulizer which, when driven by a compatible air compressor, nebulizes specific inhalable drugs for inhalation by a patient. It can be used with adult or pediatric patients.
    Device Description
    Med2000 SpA Nebulizer Compressors, Models P1 and P2: The two models (P1 and P2) differ only in minor cosmetic aspects of their shape that have no effect on performance or safety. These piston compressors are housed in a compact, irregularly-shaped white-plastic housing. Dimensions are: 60" x 4.7" x 2.4" for both compressors, and weigh 1.1 lbs. Neither models contain microprocessors. A "power cube" transformer (Med2000 Class 2 power unit) plugs into a wall outlet (2-blade plug) and provides 16 VAC to the motor via a thin 2-conductor cord that plugs into the compressor. The compressors are supplied with compatible patient tubing (2 meters), and will be marketed with a compatible medication nebulizer and respective instruction manuals. Med2000 SpA Nebulizer, Model A1/C (AndyFlow) with Accessories: The Nebulizer, Model A1/C (AndyFlow), is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. This device operates on the Venturi principle and is refillable. It is manufactured using polypropylene plastics, injection molded and is intended for single patient use. The Nebulizer, Model A1/C (AndyFlow), has several attachments that are used with the nebulizer during the nebulization process. The attachments include a mouthpiece, a 2 meter connecting tube (which connects to the lower part of the nebulizer opposite the mouthpiece), a pediatric breathing mask and an adult breathing mask. These are standard accessories for nebulizer devices. The Nebulizer, Model A1/C (AndyFlow), is a hand-held pneumatically powered nebulizer that consists of a nebulizer top that is screwed into a nebulizer cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. The device consists of a nebulizer portion (which forms and conveys an aerosol) and a reservoir portion (which contains non-aerosolized drug).
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