Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K801905 |
Device Name |
FONIX TYPE 5100 HEARING AID ANALYZER |
Applicant |
FRYE ELECTRONICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
FRYE ELECTRONICS, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 08/11/1980 |
Decision Date | 08/27/1980 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|