Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K880273 |
Device Name |
WIDEX HEARING AID MODEL C1 |
Applicant |
WIDEX HEARING AID CO., INC. |
35-23 24TH ST. |
LONG ISLAND CITY,
NY
11106
|
|
Correspondent |
WIDEX HEARING AID CO., INC. |
35-23 24TH ST. |
LONG ISLAND CITY,
NY
11106
|
|
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 01/22/1988 |
Decision Date | 03/14/1988 |
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
|
|
|