Device Classification Name |
Audiometer
|
510(k) Number |
K982566 |
Device Name |
AUTOMATIC SELF-OPERATED SCREENING AUDIOMETER DEVICE (ASAM) |
Applicant |
BAR - ADVANCED CONTROL SYSTEMS LTD. |
P.O. BOX 454 |
GINOT SHOMRON,
IL
44853
|
|
Applicant Contact |
AHAVA STEIN |
Correspondent |
BAR - ADVANCED CONTROL SYSTEMS LTD. |
P.O. BOX 454 |
GINOT SHOMRON,
IL
44853
|
|
Correspondent Contact |
AHAVA STEIN |
Regulation Number | 874.1050
|
Classification Product Code |
|
Date Received | 07/23/1998 |
Decision Date | 10/21/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
Ear Nose & Throat
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|