Device Classification Name |
Calibrator, Hearing Aid / Earphone And Analysis Systems
|
510(k) Number |
K870337 |
Device Name |
AUDIOMETER |
Applicant |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Applicant Contact |
RAVIV, PH.D. |
Correspondent |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Correspondent Contact |
RAVIV, PH.D. |
Regulation Number | 874.3310
|
Classification Product Code |
|
Date Received | 01/28/1987 |
Decision Date | 04/16/1987 |
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
|
|
|