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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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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