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510(k) Data Aggregation

    K Number
    K964340
    Device Name
    PORTAREM-3000, PFS-6000
    Manufacturer
    STARKEY LABORATORIES, INC.
    Date Cleared
    1997-01-10

    (71 days)

    Product Code
    EWO
    Regulation Number
    874.1050
    Type
    Traditional
    Panel
    Ear Nose & Throat
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PORTAREM-3000, PFS-6000

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

    The portaREM-3000,PFS-6000 is a portable hearing aid dispensing system which allows the Hearing Health Care Professional to test hearing aids to IEC/ANSI standards. It also allows for Real Ear testing, and In Situ Audiometry via the use of the probe microphone, and offers a 2cc coupler conversion in which the 2cc coupler response desired can be determined from the audiogram. Standard puretone measurement is also available. With the PFS software, which will be standard with PFS-6000 and optional for the pR-3000, prescriptive formulas, matrix and hearing aid selection, order form printing, along with other optiions described in the user manual are available.

    Device Description

    The portaREM-3000, PFS-6000 is a portable hearing aid dispensing system. It includes electronic circuitry, a 4.7" color LCD monitor with 640*480 resolution, a built-in Thermoprinter, a loudspeaker, a 3.5 inch disk drive, a test chamber for hearing aid measurement, a battery simulator, two RS-232 serial port interfaces, and a real ear probe mic. It is controlled by a fully functional PC style keyboard.

    AI/ML Overview

    The provided document is a summary of the Rastronics portaREM-3000 and Starkey PFS-6000, which are hearing aid calibrator and analysis systems. It describes the device's intended use, features, technical characteristics, and controls. However, it does not contain any information about a study to prove acceptance criteria or any reported device performance data in the format requested.

    The document primarily focuses on the device's specifications and capabilities, not on clinical performance or validation studies that would involve acceptance criteria, sample sizes, ground truth establishment, or expert evaluations. It states that "Technical specifications complies to IEC 601 and FCC part 15 class B," but this refers to electrical safety and electromagnetic compatibility standards, not performance metrics related to its intended function as a hearing aid calibrator and analysis system.

    Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details based on the provided text.

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