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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
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    K963247
    Why did this record match?
    Reference Devices :

    K963247

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called "O2n Demand-II, Victor Model OCPR-II, and Oxygen Conserving Pressure Regulator-II (OCPR-II)". This letter primarily addresses the administrative details of the clearance: correcting a product code.

    It does not contain information about acceptance criteria, study data, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or how ground truth was established.

    The document only states the "Indications For 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)."

    Therefore, I cannot provide a response that includes the requested information based on the provided text. The document is an FDA clearance letter and not a study report or clinical trial summary.

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