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510(k) Data Aggregation

    K Number
    K974096
    Device Name
    CRX DIAMOND VALVE
    Manufacturer
    PHOENIX BIOMEDICAL CORP.
    Date Cleared
    1998-12-08

    (404 days)

    Product Code
    JXG
    Regulation Number
    882.5550
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    CRX DIAMOND VALVE

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

    This device is intended for use as the principle regulating component of a CSF ITOW and pressure regaremently, used in the treatment of hydrocephalus.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "CRX DIAMOND VALVE." It confirms that the device is substantially equivalent to a legally marketed predicate device.

    However, the provided text does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

    Therefore, I cannot provide the requested information in a table or answer the specific questions about sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This type of information is typically found in the 510(k) submission itself, not in the clearance letter.

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