Duns Number:058131475
Device Description: The 8000 Hearing Aid Test System performs a broad range of hearing aid measurements from b 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 panelfor controlling the operation of the analyzer and a wide-format thermal printer. An external video monitor is used to view test results.
Catalog Number
-
Brand Name
Fonix
Version/Model Number
8000
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
ETW
Product Code Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Public Device Record Key
bc503943-a499-4b1b-b30a-bccfe64b58e8
Public Version Date
March 05, 2020
Public Version Number
3
DI Record Publish Date
August 22, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |