Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K961638 |
Device Name |
MEDILOG MPA-S |
Applicant |
OXFORD INSTRUMENTS MEDICAL SYSTEMS |
11526 53ND ST. N |
CLEARWATER,
FL
34620
|
|
Applicant Contact |
CHARLES HOLZ |
Correspondent |
OXFORD INSTRUMENTS MEDICAL SYSTEMS |
11526 53ND ST. N |
CLEARWATER,
FL
34620
|
|
Correspondent Contact |
CHARLES HOLZ |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 04/29/1996 |
Decision Date | 01/17/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|