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510(k) Data Aggregation

    K Number
    K992659
    Device Name
    O2N DEMAND-II, VICTOR MODEL OCPR-II
    Manufacturer
    THERMADYNE HOLINGS CORP.
    Date Cleared
    1999-09-03

    (25 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMADYNE HOLINGS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O2n Demand-II is intended as an oxygen conserving pressure regulator for ambulatory patients. This is the same intended use as the predicated unit (K963247).
    Device Description
    Not Found
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    K Number
    K963247
    Device Name
    VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR
    Manufacturer
    THERMADYNE HOLINGS CORP.
    Date Cleared
    1996-11-07

    (80 days)

    Product Code
    NFB
    Regulation Number
    868.5905
    Why did this record match?
    Applicant Name (Manufacturer) :

    THERMADYNE HOLINGS CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oxygen Conserving Pressure Regulator (OCPR) is a demand oxygen delivery system that delivers oxygen only during inspiration. The OCPR extends and offers cost savings.
    Device Description
    Oxygen Conserving Pressure Regulator
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