Device Classification Name |
index-generating electroencephalograph software
|
510(k) Number |
K051874 |
Device Name |
SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET |
Applicant |
PHYSIOMETRIX, INC. |
FIVE BILLERICA PARK, |
101 BILLERICA AVE. |
NORTH BILLERICA,
MA
01862
|
|
Applicant Contact |
DAWN E FRAZER |
Correspondent |
PHYSIOMETRIX, INC. |
FIVE BILLERICA PARK, |
101 BILLERICA AVE. |
NORTH BILLERICA,
MA
01862
|
|
Correspondent Contact |
DAWN E FRAZER |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/11/2005 |
Decision Date | 09/02/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|