KayPentax Electroglottograph

Product Overview

KayPentax Electroglottograph

Device Description

A graphic recorder designed for recording the changes in electrical potential or impedance, using a sensor, resulting from movement of the vocal cords during respiration and phonation. It is intended to be used to asses the degree of closure of the vocal cords during treatment of voice disorders and in the study of the laryngeal mechanism.

Environmental Conditions

  • Special Storage Condition, Specify
    • 10-40 degrees Celsius, 30-90% humidity, 700-1060 millibars air pressure

  • Device Sizes

    No Data Available

    Device Sterilization

    Device Sterile: False

    Sterilization Prior To Use: False

    Sterilization Methods: No Data Available

    Product Codes

    Code: KLX

    Device Name: Electroglottograph

    Device Class: 2

    Physical State: N/A

    Definition: N/A

    Submission Type ID: 4

    Review Panel: EN

    Review Code: N/A

    Technical Method: N

    Gmp Exempt Flag: N/A

    Life Sustain Support Flag: N

    Unclassified Reason: N/A

    Implant Flag: N

    Target Area: N/A

    Regulation Number: 874.1325

    Third Party Flag: N

    Medical Specialty: EN

    Device Identifiers

    Device Id: 04961333229888

    Device Type: Primary

    DeviceId Issuing Agency: GS1

    Contains DI Number: N/A

    Package Quantity: N/A

    Package Discontinue Date: N/A

    Package Status: N/A

    Package Type: N/A

    Educational Resources