Device Classification Name |
audiometer
|
510(k) Number |
K931324 |
Device Name |
ORBITER 922 CLINICAL AUDIOMETER |
Applicant |
MADSEN ELECTRONICS (CANADA) LTD. |
5600 ROWLAND RD. |
MINNETONKA,
MN
55343
|
|
Applicant Contact |
MARSHALL ROSNER |
Correspondent |
MADSEN ELECTRONICS (CANADA) LTD. |
5600 ROWLAND RD. |
MINNETONKA,
MN
55343
|
|
Correspondent Contact |
MARSHALL ROSNER |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 03/16/1993 |
Decision Date | 11/19/1993 |
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
|
|
|