FRYE ELECTRONICS, INC.

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Audiometer (EWO) (2) Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (2) Stimulator, Auditory, Evoked Response (GWJ) (1)

Premarket Exempt

No Yes

Clear

Fonix - B191FONIXCOLT0 Catalog Number :

Device Class : 2

Duns Number: 058131475

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

HearLab - B191HEARLABACA0 Catalog Number :

Device Class : 2

Duns Number: 058131475

Premarket Exempt : No

Product Code : GWJ

Prescription Use : No

Device Count : 1

Fonix - FONIX8000 Catalog Number :

Device Description : The 8000 Hearing Aid Test System performs a broad range of hearing aid measureme 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.

Device Class : 2

Duns Number: 058131475

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

Fonix - FONIXFP35 Catalog Number :

Device Description : The FONIX FP35 provides quick, accurate information about how well a hearing aid 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.

Device Class : 2

Duns Number: 058131475

Premarket Exempt : No

Product Code : EWO, ETW

Prescription Use : No

Device Count : 1

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