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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    VICTOR MODEL OCPR OXYGEN CONSERVING PRESSURE REGULATOR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for an "Oxygen Conserving Pressure Regulator" (OCPR). It explicitly states that the device is substantially equivalent to a legally marketed predicate device.

    Therefore, this document does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria.

    The 510(k) process is primarily a premarket notification to demonstrate that a device is at least as safe and effective as a legally marketed predicate device, often without requiring new clinical studies to prove performance against specific acceptance criteria. The clearance letter confirms "substantial equivalence" based on the information provided in the original 510(k) submission, which is not included in these excerpts.

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