Device Classification Name |
hearing aid, air-conduction, prescription
|
510(k) Number |
K935289 |
Device Name |
PRO FIT-CYBER II OPTION |
Applicant |
QUALITONE |
4931 WEST 35TH ST. |
MINNEAPOLIS,
MN
55416
|
|
Applicant Contact |
BRUCE A BROWN |
Correspondent |
QUALITONE |
4931 WEST 35TH ST. |
MINNEAPOLIS,
MN
55416
|
|
Correspondent Contact |
BRUCE A BROWN |
Regulation Number | 874.3300
|
Classification Product Code |
|
Date Received | 11/03/1993 |
Decision Date | 12/22/1993 |
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
|
|
|