Device Classification Name |
automatic event detection software for full-montage electroencephalograph
|
510(k) Number |
K950270 |
Device Name |
NMI SOFTWARE |
Applicant |
NICOLET BIOMEDICAL, INC. |
5225 VERONA RD. |
MADISON,
WI
53711
|
|
Applicant Contact |
DOUGLAS E PFRANG |
Correspondent |
NICOLET BIOMEDICAL, INC. |
5225 VERONA RD. |
MADISON,
WI
53711
|
|
Correspondent Contact |
DOUGLAS E PFRANG |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 01/23/1995 |
Decision Date | 05/15/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|