Device Classification Name |
Standard Polysomnograph With Electroencephalograph
|
510(k) Number |
K983913 |
Device Name |
MODIFICATION TO BIO-LOGIC SLEEPSCAN |
Applicant |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Applicant Contact |
NORMAN E BRUNNER |
Correspondent |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Correspondent Contact |
NORMAN E BRUNNER |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 11/04/1998 |
Decision Date | 11/25/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|