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510(k) Data Aggregation

    K Number
    K002862
    Device Name
    PRONEB ULTRA MODEL NUMBER 85B0100
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    2001-03-13

    (181 days)

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

    PARI HOLDING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K983308
    Device Name
    RC CORNET, MODEL #44F50
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    1999-06-04

    (256 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARI HOLDING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device and it was designed to exercise patient's lungs and to improve secretion clearance. The device was designed to work with PARI LC Nebulizers.
    Device Description
    The PARI RC Cornet Mucus Clearing Device is a Positive Expiratory Pressure PEP Device.
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    K Number
    K972042
    Device Name
    PARI PEP THERAPY SYSTEM
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    1997-08-05

    (64 days)

    Product Code
    BWF
    Regulation Number
    868.5690
    Why did this record match?
    Applicant Name (Manufacturer) :

    PARI HOLDING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PARI PEP Device is an Expiratory Resistance Exerciser and ii was designed to help patients exercise their lungs properly, improve secretion clearance. This expiratory resistance exerciser will be used with patients for whom a physician has prescribed lung exercise treatments at home. doctor's office, hospitals and clinics.
    Device Description
    The PARI PEP Device is an Expiratory Resistance Exerciser. The PARI PEP was designed to work with the PARI Nebulizers.
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    K Number
    K963924
    Device Name
    LC STAR REUSABLE NEBULIZER 22F50 AND LC STAR DISPOSABLE NEBULIZER 22F70
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    1996-12-10

    (71 days)

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

    PARI HOLDING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K962072
    Device Name
    PRONEB TURBO COMPRESSOR MODEL 38V0200
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    1996-08-21

    (85 days)

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

    PARI HOLDING CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K960675
    Device Name
    WALKHALER PORTABLE COMPRESSOR MODEL 45F70
    Manufacturer
    PARI HOLDING CO.
    Date Cleared
    1996-05-17

    (87 days)

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

    PARI HOLDING CO.

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

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