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510(k) Data Aggregation

    K Number
    K082056
    Device Name
    ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1
    Manufacturer
    LIFE-TECH, INC.
    Date Cleared
    2008-11-07

    (109 days)

    Product Code
    FFX
    Regulation Number
    876.1725
    Type
    Traditional
    Panel
    Gastroenterology/Urology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ANORECTAL MANOMETRY SOFTWARE OPTION ARM-1

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

    The ARM-1 is interdad to enable the Urolab equipment to measure and record the functioning of a patient's anorectal. function.

    Device Description

    Ano-Rectal Manometry Option (ARM-1)

    AI/ML Overview

    I am sorry, but the provided text does not contain information regarding acceptance criteria, device performance, study details (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods), or multi-reader multi-case comparative effectiveness studies. The document is an FDA 510(k) clearance letter for a medical device called "Ano-Rectal Manometry Option (ARM-1)", indicating that the device is substantially equivalent to a legally marketed predicate device. It specifies the indications for use but does not delve into the technical validation studies.

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