Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K012306 |
Device Name |
AUDIOSCAN VERIFIT, MODEL VF-1 |
Applicant |
ETYMONIC DESIGN, INC. |
41 BYRON AVE. |
DORCHESTER, ONTARIO,
CA
NOL 1GO
|
|
Applicant Contact |
WILLIAM A COLE |
Correspondent |
ETYMONIC DESIGN, INC. |
41 BYRON AVE. |
DORCHESTER, ONTARIO,
CA
NOL 1GO
|
|
Correspondent Contact |
WILLIAM A COLE |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 07/23/2001 |
Decision Date | 09/21/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|