Device Classification Name |
Audiometer
|
510(k) Number |
K900197 |
Device Name |
THE MAX SYSTEM, MODEL: BASIC, 1000,2000 AUDIOMETER |
Applicant |
SOUND LINKED DATA, INC. |
5444 TIMBERLEA BLVD. |
MISSISSAUGA, ONTARIO |
CANADA L4W 2TF,
CA
|
|
Applicant Contact |
T MACTAGGART |
Correspondent |
SOUND LINKED DATA, INC. |
5444 TIMBERLEA BLVD. |
MISSISSAUGA, ONTARIO |
CANADA L4W 2TF,
CA
|
|
Correspondent Contact |
T MACTAGGART |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 01/16/1990 |
Decision Date | 04/17/1991 |
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
|
|
|