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FDA 510(k) Application Details - K221563
Device Classification Name
Reduced- Montage Standard Electroencephalograph
More FDA Info for this Device
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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More FDA Info for this Product Code
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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