HearLab

GUDID B191HEARLABACA0

FRYE ELECTRONICS, INC.

Evoked-potential graphic recording system

• Primary Device ID: B191HEARLABACA0
• NIH Device Record Key: 0faf6949-57c5-4e26-9c50-cb58390ba812
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HearLab
• Version Model Number: ACA
• Company DUNS: 058131475
• Company Name: FRYE ELECTRONICS, 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: 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: 5036200722
• Email: sales@frye.com
• Phone: 5036200722
• Email: sales@frye.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B191HEARLABACA0 [Primary]

FDA Product Code

• GWJ: Stimulator, Auditory, Evoked Response

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

Devices Manufactured by FRYE ELECTRONICS, INC.

• FONIX8000 - Fonix: 2020-03-05 The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, ba
• FONIXFP35 - Fonix: 2020-03-05 The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It uses a graphical display or numerical
• B191FONIXCOLT0 - Fonix: 2018-03-29
• B191HEARLABACA0 - HearLab: 2018-03-29
• B191HEARLABACA0 - HearLab: 2018-03-29