Device Classification Name |
Audiometer
|
510(k) Number |
K883478 |
Device Name |
DIAGNOSTIC AUDIOMETER, MODEL MIDIMATE 602 |
Applicant |
MADSEN ELECTRONICS (CANADA) LTD. |
2370 SPEERS ROAD |
P.O. BOX 535 |
OAKVILLE, ONTARIO,
CA
L6J5B4
|
|
Applicant Contact |
ZOILA FLORES |
Correspondent |
MADSEN ELECTRONICS (CANADA) LTD. |
2370 SPEERS ROAD |
P.O. BOX 535 |
OAKVILLE, ONTARIO,
CA
L6J5B4
|
|
Correspondent Contact |
ZOILA FLORES |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 08/16/1988 |
Decision Date | 11/17/1988 |
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
|
|
|