| Device Classification Name |
device, galvanic skin response measurement |
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|---|---|---|---|---|---|
| 510(k) Number | K111308 | ||||
| Device Name | ZYTO HAND CRADLE | ||||
| Applicant |
|
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| Applicant Contact | vaughn r cook | ||||
| Correspondent |
|
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| Correspodent Contact | vaughn r cook | ||||
| Regulation Number | 882.1540 | ||||
| Classification Product Code |
|
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| Date Received | 05/10/2011 | ||||
| Decision Date | 08/30/2011 | ||||
| Decision |
substantially equivalent (SESE) |
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| Regulation Medical Specialty |
Neurology |
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| 510k Review Panel |
Neurology |
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| summary |
summary |
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| Type | Traditional | ||||
| Reviewed by Third Party | No | ||||
| Combination Product |
No |