Device Classification Name |
Device, Galvanic Skin Response Measurement
|
510(k) Number |
K111308 |
Device Name |
ZYTO HAND CRADLE |
Applicant |
ZYTO TECHNOLOGIES, INC |
387 SOUTH 520 WEST |
SUITE 200 |
LINDON,
UT
84042
|
|
Applicant Contact |
VAUGHN R COOK |
Correspondent |
ZYTO TECHNOLOGIES, INC |
387 SOUTH 520 WEST |
SUITE 200 |
LINDON,
UT
84042
|
|
Correspondent Contact |
VAUGHN R COOK |
Regulation Number | 882.1540
|
Classification Product Code |
|
Date Received | 05/10/2011 |
Decision Date | 08/30/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|