FDA 510(k) Application Details - K170659

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

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510(K) Number K170659
Device Name Stimulator, Nerve, Transcutaneous, Over-The-Counter
Applicant IQ Technologies Inc.
6672 Spencer St., Ste 800
Las Vegas, NV 89119 US
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Contact Elli Josef
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Regulation Number 882.5890

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Classification Product Code NUH
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Date Received 03/03/2017
Decision Date 05/26/2017
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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