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510(k) Data Aggregation

    K Number
    K093388
    Device Name
    SMART CAPNOLINE GUARDIAN
    Manufacturer
    ORIDION MEDICAL 1987 LTD.
    Date Cleared
    2010-03-04

    (125 days)

    Product Code
    CCK
    Regulation Number
    868.1400
    Type
    Traditional
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    SMART CAPNOLINE GUARDIAN

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

    The Smart CapnoLine Guardian™ is intended to sample CO2 and administer supplemental oxygen, for patients who can wear a 60 fr. bite block, during upper endoscopy type procedures. The set is intended for single patient use only.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain specific details about acceptance criteria, a study proving device performance, sample sizes, expert qualifications, or ground truth establishment. The document is a 510(k) premarket notification letter from the FDA to Oridion Medical 1987 Limited regarding their Smart CapnoLine Guardian™ device, confirming its substantial equivalence to a legally marketed predicate device.

    It primarily covers:

    • Confirmation of substantial equivalence.
    • Regulatory information and compliance requirements for the device.
    • Contact information for regulatory questions.
    • The product's indications for use.

    Therefore, I cannot provide the requested table and study details based on the given input.

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