Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K931320 |
Device Name |
RIONET HEARING AID HB-53W |
Applicant |
RION CO. LTD. DBA RION ACOUSTIC DEVICE |
C/O AUTHORIZED HEARING SYSTEMS |
806 BEAVER STREET |
BRISTOL,
PA
19007
|
|
Applicant Contact |
HENRY C SMITH |
Correspondent |
RION CO. LTD. DBA RION ACOUSTIC DEVICE |
C/O AUTHORIZED HEARING SYSTEMS |
806 BEAVER STREET |
BRISTOL,
PA
19007
|
|
Correspondent Contact |
HENRY C SMITH |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 03/16/1993 |
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
|
|
|