Device Classification Name |
Automatic Event Detection Software For Polysomnograph With Electroencephalograph
|
510(k) Number |
K963631 |
Device Name |
SLEEP STUDY ANALYSIS (SSA) VERSION 96.10 |
Applicant |
OMEGA RESULTS |
3322 SHORECREST, SUITE 235 |
DALLAS,
TX
75235
|
|
Applicant Contact |
KAY SPIEKERMAN EASON |
Correspondent |
OMEGA RESULTS |
3322 SHORECREST, SUITE 235 |
DALLAS,
TX
75235
|
|
Correspondent Contact |
KAY SPIEKERMAN EASON |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 09/11/1996 |
Decision Date | 04/02/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|