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510(k) Data Aggregation

    K Number
    K002104
    Device Name
    COMBINED PHYSIOLOGICAL MONITORING SYSTEM
    Manufacturer
    MARYROSE CUSIMANO, PH.D. & SCOTT ZEFF
    Date Cleared
    2000-10-10

    (90 days)

    Product Code
    IKN
    Regulation Number
    890.1375
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    COMBINED PHYSIOLOGICAL MONITORING SYSTEM

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    Device Description
    AI/ML Overview
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    K Number
    K971708
    Device Name
    PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE
    Manufacturer
    J & J ENGINEERING, INC.
    Date Cleared
    1998-02-18

    (286 days)

    Product Code
    HCC,NOV
    Regulation Number
    882.5050
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    PHYSIOLOGICAL MONITORING & BIOFEEDBACK TRAINING DEVICE

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

    This device is intended to be used for physiological monitoring, biofeedback training, incontinence, relaxation training, muscle reeducation and research.

    Device Description

    Physiological Monitoring & Biofeedback Instrument

    AI/ML Overview

    I apologize, but the provided text from the FDA 510(k) clearance letter for the "J&L I-410 Physiological Monitoring & Biofeedback Instrument" (K971708) does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.

    The document is a standard FDA clearance letter, which states that the device is "substantially equivalent" to predicate devices and can therefore be marketed. It outlines regulatory requirements and provides contact information. It does not include technical specifications, performance metrics, or details of any studies conducted to validate the device's performance against specific acceptance criteria.

    Therefore, I cannot provide the requested information in the table or answer the subsequent questions based on the provided text.

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