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FDA 510(k) Application Details - K152216
Device Classification Name
Device, Galvanic Skin Response Measurement
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510(K) Number
K152216
Device Name
Device, Galvanic Skin Response Measurement
Applicant
LD TECHNOLOGY LLC
100N. BIscayne Blvd, suite 500
Miami, FL 33132 US
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Contact
Albert MAAREK
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Regulation Number
882.1540
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Classification Product Code
GZO
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More FDA Info for this Product Code
Date Received
08/07/2015
Decision Date
09/24/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
NE - Neurology
Review Advisory Committee
NE - Neurology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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