Duns Number:058131475
Device Description: The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It The FONIX FP35 provides quick, accurate information about how well a hearing aid works. It uses a graphical display or numerical table to show how much amplification the aid provides, which frequencies it amplifies, and how much distortion is creates. The FP35 analyzer is meant to be used primarily by hearing health professionals who fit hearing aids on hearing-impaired adults and children throughout the world.
Catalog Number
-
Brand Name
Fonix
Version/Model Number
FP35
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
ETW
Product Code Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Public Device Record Key
afa78752-23c5-4e2c-8c69-3866db69b161
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 |