Device Classification Name |
audiometer
|
510(k) Number |
K953884 |
Device Name |
PROPHET |
Applicant |
QUALITONE |
4931 WEST 35TH ST. |
MINNEAPOLIS,
MN
55416
|
|
Applicant Contact |
BRUCE BROWN |
Correspondent |
QUALITONE |
4931 WEST 35TH ST. |
MINNEAPOLIS,
MN
55416
|
|
Correspondent Contact |
BRUCE BROWN |
Regulation Number | 874.1050
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/17/1995 |
Decision Date | 10/27/1995 |
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
|
|
|