FDA 510(k) Application Details - K221563

Device Classification Name Reduced- Montage Standard Electroencephalograph

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510(K) Number K221563
Device Name Reduced- Montage Standard Electroencephalograph
Applicant Neurosteer Inc.
375 South End Avenue Suite 26C
New York, NY 10280 US
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Contact Nathan Intrator
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Regulation Number 882.1400

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Classification Product Code OMC
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Date Received 05/31/2022
Decision Date 10/24/2022
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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