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510(k) Data Aggregation

    K Number
    K093308
    Device Name
    MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD
    Manufacturer
    NIDEK MEDICAL PRODUCTS, INC.
    Date Cleared
    2010-01-14

    (84 days)

    Product Code
    CAW
    Regulation Number
    868.5440
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The proposed devices are intended solely for medical use in oxygen therapy programs under the supervision of a physician. This device is available by prescription only and is not intended to support or sustain life.

    Device Description

    Mark 5 Nuvo 8 OCSI
    Mark 5 Nuvo 8 STD

    AI/ML Overview

    I'm sorry, but this document does not contain the information requested. This is an FDA 510(k) clearance letter for the Mark 5 Nuvo 8 OCSI and Mark 5 Nuvo 8 STD portable oxygen generators. It states that the devices are substantially equivalent to legally marketed predicate devices and outlines general regulatory compliance requirements. However, it does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any information related to AI or MRMC comparative effectiveness studies. This type of information would typically be found in the 510(k) submission itself, not the clearance letter.

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