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510(k) Data Aggregation

    K Number
    K122857
    Device Name
    HOPE CONTINUOUS NEBULIZER MODEL HOPE-11310, HEART NEBULIZER MODEL HEART-100609, THERAMIST NEBULIZER MODEL THERAMIST-3100
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2012-11-07

    (50 days)

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

    PEGASUS RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Res-Q Continuous Nebulizer is a device to used under the medical supervision in hospital, nursing homes, extended care facilities and outpatient clinics. The Res-Q Continuous Nebulizer is a high output nebulizer to be used to deliver aerosolized medications and diagnostic formulations. It provides additional hydration to help loosen secretions for patients whom extended therapy is required. Patient population: Asthma, pneumonia, COPD, or any other condition in which sympathomimetic ammines, parasympathetic ammines, or other appropriate medications would be nebulized. The Res-Q Continuous Nebulizer requires 50 psig source gas. HE air or oxygen may be added via Multi-gas inlet.
    Device Description
    Not Found
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    K Number
    K020700
    Device Name
    PMH 5000 HEATED HUMIDIFIER FOR RESPIRATORY THERAPY
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2004-04-26

    (784 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PEGASUS RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PMH Humidifier is intended to add moisture and To warm the breathing gases for administration to a patient. The humidifier is intended for use with flows of 5 liters per Minute or more through the humidifier.
    Device Description
    Not Found
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    K Number
    K013856
    Device Name
    PMH 1000 HEATED HUMIDIFIER
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2003-02-21

    (472 days)

    Product Code
    BTT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PEGASUS RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PMH 1000 Heated Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.
    Device Description
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    K Number
    K983783
    Device Name
    HEATED HUMIDIFIER
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    2000-10-24

    (728 days)

    Product Code
    BTT, DAT
    Regulation Number
    868.5450
    Why did this record match?
    Applicant Name (Manufacturer) :

    PEGASUS RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Patient End Humidifier is intended to add moisture and to warm the breathing gases for administration to a patient.
    Device Description
    Not Found
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    K Number
    K962534
    Device Name
    THERA-MIST NEBULIZER MODEL-P3000
    Manufacturer
    PEGASUS RESEARCH CORP.
    Date Cleared
    1997-02-28

    (245 days)

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

    PEGASUS RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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