FDA 510(k) Application Details - K131290

Device Classification Name Stimulator, Nerve, Transcutaneous, Over-The-Counter

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510(K) Number K131290
Device Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant IQ TECHNOLOGIES INC.
1631 E. Sunset Road
Suite C 103
Las Vegas, NV 89119 US
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Contact ELI JOSEF
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Regulation Number 882.5890

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Classification Product Code NUH
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Date Received 05/06/2013
Decision Date 08/06/2014
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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