Device Classification Name |
Index-Generating Electroencephalograph Software
|
510(k) Number |
K001069 |
Device Name |
MODEL 4000 EEG MONITOR WITH PSI (PSA4000) |
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 | 04/03/2000 |
Decision Date | 06/30/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|