Device Classification Name |
index-generating electroencephalograph software
|
510(k) Number |
K020218 |
Device Name |
SNAP EEG MONITOR |
Applicant |
NICOLET BIOMEDICAL, INC. |
800 LEVANGER LN. |
STOUGHTON,
WI
53589
|
|
Applicant Contact |
Gary Syring |
Correspondent |
NICOLET BIOMEDICAL, INC. |
800 LEVANGER LN. |
STOUGHTON,
WI
53589
|
|
Correspondent Contact |
Gary Syring |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/22/2002 |
Decision Date | 04/22/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|