Two Channel Electroglottograph EG2-PCX2

GUDID 00860011116905

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

Glottal Enterprises, Inc.

Electroglottograph

• Primary Device ID: 00860011116905
• NIH Device Record Key: 62bcbbce-9e45-4351-9c53-0b7b7b676e0a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Two Channel Electroglottograph EG2-PCX2
• Version Model Number: EG2-PCX2
• Company DUNS: 114191554
• Company Name: Glottal Enterprises, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860011116905 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K901609

FDA Product Code

• KLX: Electroglottograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-09
• Device Publish Date: 2024-07-01