Two Channel Electroglottograph EG2-PCX2

Basic Information

• Brand Name: Two Channel Electroglottograph EG2-PCX2
• Primary DI: 00860011116905
• Version / Model: EG2-PCX2
• Company Name: Glottal Enterprises, Inc.
• Labeler DUNS: 114191554
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-07-01
• Public Version: 1
• Public Version Date: 2024-07-09
• Public Version Status: New
• Public Device Record Key: 62bcbbce-9e45-4351-9c53-0b7b7b676e0a

Device Description

Device for the non-invasive measurement of vocal fold contact area.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KLX	Electroglottograph	Ear, Nose, Throat	874.1325	2

GMDN Terms

Code	Name	Definition	Implantable	Status
16034	Electroglottograph	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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860011116905	GS1

Premarket Submissions

Submission Number	Supplement Number
K901609	000