KayPentax Electroglottograph

KayPentax Electroglottograph
ELECTROGLOTTOGRAPH - 6103

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