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510(k) Data Aggregation

    K Number
    K013988
    Device Name
    MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R
    Manufacturer
    MILLIPORE CORP.
    Date Cleared
    2002-04-04

    (121 days)

    Product Code
    BSN
    Regulation Number
    868.5130
    Type
    Special
    Panel
    Anesthesiology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 R

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

    Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.

    Device Description

    Millex- GP Sterilizing Filter Unit

    AI/ML Overview

    The provided text is a letter from the FDA regarding a 510(k) premarket notification for a medical device. It does not contain any information about acceptance criteria for device performance, a study proving the device meets those criteria, or any details related to AI/algorithm performance.

    Therefore, I cannot answer the questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth establishment based on the provided text.

    The document primarily focuses on:

    • Device Name: Millex- GP Sterilizing Filter Unit
    • Regulation Number/Name: 868.5130, Anesthesia Conduction Filter
    • Regulatory Class: II
    • Product Code: BSN
    • Indications for Use: Intended for use as a syringe filter to sterilize or ultraclean low volume solutions in direct patient care and pharmacy admixture applications.
    • FDA's finding: Substantially equivalent to legally marketed predicate devices.
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