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 |