Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K042315 |
Device Name |
CEREBRAL STATE MONITOR - CSM |
Applicant |
DANMETER A/S |
KILDEMOSEVEJ 13 |
ODENSE C,
DK
DK-5000
|
|
Applicant Contact |
HANNE NIELSEN |
Correspondent |
DANMETER A/S |
KILDEMOSEVEJ 13 |
ODENSE C,
DK
DK-5000
|
|
Correspondent Contact |
HANNE NIELSEN |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/26/2004 |
Decision Date | 01/21/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|