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FDA 510(k) Application Details - K181179
Device Classification Name
More FDA Info for this Device
510(K) Number
K181179
Device Name
BrainScope One
Applicant
BrainScope Company Inc.
4350 East West Hwy, Ste 1050
Bethesda, MD 20814 US
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Contact
Michael E Singer
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Regulation Number
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Classification Product Code
PIW
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Date Received
05/02/2018
Decision Date
05/18/2018
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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