Fonix

GUDID B191FONIXCOLT0

FRYE ELECTRONICS, INC.

Speech audiometer

• Primary Device ID: B191FONIXCOLT0
• NIH Device Record Key: d1f9a170-3bda-49db-9beb-21d398056b2a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fonix
• Version Model Number: Colt
• Company DUNS: 058131475
• Company Name: FRYE ELECTRONICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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

Customer Support Contacts

• Phone: 5036202722
• Email: sales@frye.com
• Phone: 5036202722
• Email: sales@frye.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B191FONIXCOLT0 [Primary]

FDA Product Code

• EWO: Audiometer

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-02-11

On-Brand Devices [Fonix]

• B191FONIXCOLT0: Colt
• FONIXFP35: The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It uses
• FONIX8000: The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic,