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FDA 510(k) Application Details - K211452
Device Classification Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
More FDA Info for this Device
510(K) Number
K211452
Device Name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Applicant
Austrian Institute of Technology GmbH
Giefinggasse 4
Vienna 1210 AT
Other 510(k) Applications for this Company
Contact
Tilmann Kluge
Other 510(k) Applications for this Contact
Regulation Number
882.1400
More FDA Info for this Regulation Number
Classification Product Code
OMB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/10/2021
Decision Date
12/02/2021
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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