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510(k) Data Aggregation

    K Number
    K955398
    Device Name
    FORMULATION PREPARATION DEVICE
    Manufacturer
    B. BRAUN MEDICAL, INC.
    Date Cleared
    1996-04-04

    (132 days)

    Product Code
    LHI
    Regulation Number
    880.5440
    Type
    Traditional
    Panel
    General Hospital
    Reference & Predicate Devices
    K792227
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.

    Device Description

    The Formulation Prepration Device. The Formulation Device is used for preparing and dispensing medications from rubber stoppered vials.

    AI/ML Overview

    The provided text describes a medical device called the "Formulation Preparation Device" and its substantial equivalence to another device. However, it does not contain the information requested in the prompt regarding acceptance criteria, device performance metrics, study details, or ground truth establishment.

    The document is a 510(k) summary for a relatively old device (1995) and focuses on demonstrating substantial equivalence to a predicate device based on materials, form, and intended use. It mentions that "All finished products are tested and must meet all required release specifications before distribution" and refers to "physical testing" and "visual examination," but it does not specify what those specifications or the results of those tests are.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study design, sample sizes, expert qualifications, or ground truth that you've asked for. The information simply isn't present in the provided text.

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