Device Classification Name |
Hearing Aid, Air-Conduction, Prescription
|
510(k) Number |
K844985 |
Device Name |
IN THE EAR MODEL X-ITE 84 |
Applicant |
BERNAFON, INC. |
1125 GLOBE AVE. |
P.O. BOX 1160 |
MOUNTAINSIDE,
NJ
07092
|
|
Applicant Contact |
TED MIKSIEWICA |
Correspondent |
BERNAFON, INC. |
1125 GLOBE AVE. |
P.O. BOX 1160 |
MOUNTAINSIDE,
NJ
07092
|
|
Correspondent Contact |
TED MIKSIEWICA |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 12/26/1984 |
Decision Date | 01/23/1985 |
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
|
|
|