Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K861728 |
Device Name |
RIONET HEARING AID |
Applicant |
RION ACOUSTIC INSTRUMENTS, INC. |
912 W. 223RD ST. |
TORRANCE,
CA
90502
|
|
Applicant Contact |
MASATSUGU OTSUKA |
Correspondent |
RION ACOUSTIC INSTRUMENTS, INC. |
912 W. 223RD ST. |
TORRANCE,
CA
90502
|
|
Correspondent Contact |
MASATSUGU OTSUKA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 05/06/1986 |
Decision Date | 05/27/1986 |
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
|
|
|