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510(k) Data Aggregation

    K Number
    K042547
    Device Name
    DRAGON HEART PISTON SYRINGE
    Manufacturer
    DRAGON HEART MEDICAL DEVICES CO., LTD.
    Date Cleared
    2004-12-01

    (72 days)

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

    The Dragon Heart Piston Syringe is design for medical purposes to inject fluids into or withdraw fluids from the body. The syringe has a graduated barrel, a plunger, a hub and a needle.

    Device Description

    The syringe has a graduated barrel, a plunger, a hub and a needle.

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the Dragon Heart Piston Syringe does not contain the information needed to answer your request regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth methods.

    This document is a clearance letter, which confirms that the device is substantially equivalent to a legally marketed predicate device and can be marketed. It does not typically include the detailed technical study reports or performance data that would address your specific questions about acceptance criteria and study methodologies.

    To obtain that information, you would generally need to refer to the full 510(k) submission document, which is not provided here.

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