Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K930328 |
Device Name |
NAVIGATOR & TRAVELER EVOKED POSTENTIAL PRODUCT |
Applicant |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Applicant Contact |
CATHY BUHNER |
Correspondent |
BIO-LOGIC SYSTEMS CORP. |
ONE BIO-LOGIC PLAZA |
MUNDELEIN,
IL
60060 -3700
|
|
Correspondent Contact |
CATHY BUHNER |
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 01/22/1993 |
Decision Date | 07/02/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|