Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K862169 |
Device Name |
ALPHA ALL-IN-THE-EAR HEARING AID |
Applicant |
AUTHORIZED HEARING SYSTEMS, INC. |
P.O. BOX 309 |
LEVITTOWN,
PA
19058
|
|
Applicant Contact |
AMBER J SMITH |
Correspondent |
AUTHORIZED HEARING SYSTEMS, INC. |
P.O. BOX 309 |
LEVITTOWN,
PA
19058
|
|
Correspondent Contact |
AMBER J SMITH |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 06/09/1986 |
Decision Date | 07/22/1986 |
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
|
|
|