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510(k) Data Aggregation

    K Number
    K971664
    Device Name
    RAMY PISTON SYRINGE
    Manufacturer
    ALSHIFA MEDICAL SYRINGES MFG. CO., LTD.
    Date Cleared
    1997-07-25

    (80 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

    General purpose single use piston syringe used to withdraw or inject first into the body. The device is sold as a sold as a sold as a sold and in a sold and is monther is sold device is sold device is not of The device is not intended for use with any specific drugs or biologics. It is sold as a prescription device with needle . attached and ready for use.

    Device Description

    RAMY Piston Syringe

    AI/ML Overview

    I'm sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (Ramy Syringe). It does not contain information about acceptance criteria for a study, device performance data, sample sizes, expert qualifications, or details about comparative effectiveness studies.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the input provided. The document primarily discusses regulatory clearance based on substantial equivalence to an existing device.

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