Device Classification Name |
audiometer
|
510(k) Number |
K904544 |
Device Name |
ACOUSTIC APPRAISER CD-2 AUDIOMETER/MASTER HEAR.AID |
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 | 874.1050
|
Classification Product Code |
|
Date Received | 10/04/1990 |
Decision Date | 10/31/1990 |
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
|
|
|