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510(k) Data Aggregation

    K Number
    K964230
    Device Name
    CORELIFE
    Manufacturer
    CORE HEALTHCARE LTD.
    Date Cleared
    1997-07-24

    (274 days)

    Product Code
    FMF
    Regulation Number
    880.5860
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This device is used to inject fluids into or withdraw fluids from the body.

    Device Description

    CORELIFE (PISTON SYRINGE)

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device named "CORELIFE (PISTON SYRINGE)". It states that the device is substantially equivalent to legally marketed predicate devices.

    However, the document is a clearance letter and does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies.

    Therefore, I cannot provide the requested information from the given text. The document is solely an FDA regulatory approval and does not delve into the technical details of device validation studies.

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