Device Classification Name |
Electromyograph, Diagnostic
|
510(k) Number |
K842613 |
Device Name |
COMPACT VISUAL |
Applicant |
NICOLET BIOMEDICAL INSTRUMENTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
NICOLET BIOMEDICAL INSTRUMENTS |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 890.1375
|
Classification Product Code |
|
Date Received | 07/05/1984 |
Decision Date | 07/20/1984 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|