FONIX, MODEL 7000


Device Classification Name

calibrator, hearing aid / earphone and analysis systems

510(k) Number K022510
Device Name FONIX, MODEL 7000
Original Applicant
FRYE ELECTRONICS, INC.
9826 s.w. tigard st.
tigard, 
OR 
97223

Original Contact kristina frye
Regulation Number 874.3310
Classification Product Code
ETW  
Date Received 07/30/2002
Decision Date 08/27/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Ear Nose & Throat

510k Review Panel

Ear Nose & Throat

statement

statement

Type Abbreviated
Reviewed by Third Party No

Combination Product

No