Device Classification Name |
device, sleep assessment
|
510(k) Number |
K862766 |
Device Name |
EPISON, ALERTING SYSTEM FOR EPILEPTICS |
Applicant |
ZYGO INDUSTRIES, INC. |
P.O. BOX 1008 |
PORTLAND,
OR
97207 -1008
|
|
Applicant Contact |
LAWRENCE H WEISS |
Correspondent |
ZYGO INDUSTRIES, INC. |
P.O. BOX 1008 |
PORTLAND,
OR
97207 -1008
|
|
Correspondent Contact |
LAWRENCE H WEISS |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 07/22/1986 |
Decision Date | 03/13/1987 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|