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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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ELI JOSEF
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Regulation Number
882.5890
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Classification Product Code
NUH
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More FDA Info for this Product Code
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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