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510(k) Data Aggregation

    K Number
    K972383
    Device Name
    EASY-JET DEVICE
    Manufacturer
    A. STEIN - REGULATORY AFFAIRS CONSULTING
    Date Cleared
    1999-11-23

    (880 days)

    Product Code
    KLZ,DAT
    Regulation Number
    874.3850
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    KLZ

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

    The Easy-Ject device is an automatic injection device with a cooling mechanism, for insulin injection and needle withdrawal.

    Device Description

    automatic injection device with a cooling mechanism

    AI/ML Overview

    Information about acceptance criteria and a study proving a device meets them is not available in the provided document.

    The document is a 510(k) clearance letter from the FDA for the "Easy-Ject Device," an automatic injector with a cooling mechanism for insulin injection and needle withdrawal. It confirms the device's substantial equivalence to a predicate device and allows it to be marketed.

    The FDA letter and the "Indications for Use Statement" do not contain:

    • A table of acceptance criteria or reported device performance.
    • Details about a study, sample sizes, data provenance, expert qualifications, or adjudication methods for establishing ground truth.
    • Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
    • Details on training set size or how ground truth was established for a training set.

    The document focuses on the regulatory clearance process based on substantial equivalence, not on a detailed performance study against specific acceptance criteria.

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