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510(k) Data Aggregation

    K Number
    K984569
    Device Name
    AB2 MED-FLO SOLUTION SET
    Manufacturer
    AB2 MEDICAL PRODUCTS, LLP
    Date Cleared
    1999-08-12

    (232 days)

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

    The AU2 Med-I'lo Solution Sct is intended to be used to provide a sterile pathway from the solution source (T.V.bag) to the patient's intravascular catheter. The flow of the solution is accomplisched i by gravity flow.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called the "AB2 Med-Flo Solution Set." It's a regulatory approval document, not a study report or technical specification document detailing acceptance criteria and performance data.

    Therefore, the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in the provided text. The letter only states that the device is "substantially equivalent" to previously marketed devices and can be marketed subject to general controls.

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