Device Classification Name |
Audiometer
|
510(k) Number |
K002200 |
Device Name |
CAPELLA |
Applicant |
MADSEN ELECTRONICS, INC. |
5600 ROWLAND RD., SUITE 275 |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
JIM BERGERSON |
Correspondent |
MADSEN ELECTRONICS, INC. |
5600 ROWLAND RD., SUITE 275 |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
JIM BERGERSON |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 07/20/2000 |
Decision Date | 08/25/2000 |
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
|
|
|