FDA 510(k) Application Details - K053004

Device Classification Name Device, Galvanic Skin Response Measurement

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510(K) Number K053004
Device Name Device, Galvanic Skin Response Measurement
Applicant BIOMERIDIAN, INT.
12411 SOUTH 265 WEST, SUITE F
DRAPER, UT 84020-8671 US
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Contact GENE SWIFT
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Regulation Number 882.1540

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Classification Product Code GZO
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Date Received 10/26/2005
Decision Date 01/13/2006
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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