Device Classification Name |
Device, Biofeedback
|
510(k) Number |
K953257 |
Device Name |
ORALSENSOR |
Applicant |
CYCURA CORP. |
P.O. BOX 364 |
ROCKLIN,
CA
95677
|
|
Applicant Contact |
KENT ANDERSON |
Correspondent |
CYCURA CORP. |
P.O. BOX 364 |
ROCKLIN,
CA
95677
|
|
Correspondent Contact |
KENT ANDERSON |
Regulation Number | 882.5050
|
Classification Product Code |
|
Date Received | 07/12/1995 |
Decision Date | 02/27/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|