Identity
- Trade Name
- Fonix FDA UDI
- Generic Name
- Hearing aid tester, electrical FDA UDI
- Device Name
- The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, battery current drain, and frequency response to advanced tests of digital processing delay and phase. The FONIX 8000 is composed of a main electronics module with a front panel for controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results. FDA UDI
- Model / Reference
- 8000 FDA UDI
- Description
- The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from basic, everyday tests of distortion, battery current drain, and frequency response to advanced tests of digital processing delay and phase. The FONIX 8000 is composed of a main electronics module with a front panel for controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results. FDA UDI
Identifiers
- Primary DI / UDI-DI
- FONIX8000 FDA UDI
- FDA Product Code
- ETW FDA UDI
- GMDN Term
- Hearing aid tester, electrical FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3310 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Hearing aid tester, electrical
Fonix by Frye Electronics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Frye Electronics, Inc.
Sources (1)
- FDA UDI bc503943-a499-4b1b-b30a-bccfe64b58e8 34 fields · synced May 31, 2026