Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K931023 |
Device Name |
IN-THE-EAR HEARING AID |
Applicant |
HEARING IMPROVEMENT |
2929 WASHINGTON BLVD. |
OGDEN,
UT
84401
|
|
Applicant Contact |
ROSS WESTERN |
Correspondent |
HEARING IMPROVEMENT |
2929 WASHINGTON BLVD. |
OGDEN,
UT
84401
|
|
Correspondent Contact |
ROSS WESTERN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/01/1993 |
Decision Date | 05/05/1993 |
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
|
|
|