Device Classification Name |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
|
510(k) Number |
K891383 |
Device Name |
MEDILOG 9200 EEG REPLAY/ANALYSIS SYSTEM |
Applicant |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Applicant Contact |
MICHAEL J SMITH |
Correspondent |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Correspondent Contact |
MICHAEL J SMITH |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/09/1989 |
Decision Date | 06/01/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|