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FDA 510(k) Application Details - K222450
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K222450
Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant
LVIS Corporation
2600 East Bayshore Rd.
Palo Alto, CA 94303 US
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Contact
William Antilla
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OMB
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More FDA Info for this Product Code
Date Received
08/15/2022
Decision Date
06/09/2023
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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