Device Classification Name |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
|
510(k) Number |
K002622 |
Device Name |
BIOSLEEP |
Applicant |
OXFORD BIOSIGNALS LIMITED |
OXFORD SCIENCE PARK |
OXFORD, OX4 4 GA,
GB
OX4 4
|
|
Applicant Contact |
PAULINE A HOBDAY |
Correspondent |
OXFORD BIOSIGNALS LIMITED |
OXFORD SCIENCE PARK |
OXFORD, OX4 4 GA,
GB
OX4 4
|
|
Correspondent Contact |
PAULINE A HOBDAY |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 08/23/2000 |
Decision Date | 10/23/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|