Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K903860 |
Device Name |
ITE HEARING AID, SAAPHIRE MODEL |
Applicant |
IMPROVED HEARING SERVICE, INC. |
2525 A E. BELL RD. |
PHOENIX,
AZ
|
|
Applicant Contact |
RUDISILL II |
Correspondent |
IMPROVED HEARING SERVICE, INC. |
2525 A E. BELL RD. |
PHOENIX,
AZ
|
|
Correspondent Contact |
RUDISILL II |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 07/30/1990 |
Decision Date | 10/09/1990 |
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
|
|
|