Device Classification Name |
non-normalizing quantitative electroencephalograph software
|
510(k) Number |
K850541 |
Device Name |
SLEEP STAGER |
Applicant |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Applicant Contact |
JOHN K LAURIE |
Correspondent |
OXFORD MEDILOG, INC. |
11526 53RD. ST. N. |
CLEARWATER,
FL
33520
|
|
Correspondent Contact |
JOHN K LAURIE |
Regulation Number | 882.1400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/11/1985 |
Decision Date | 08/02/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|