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510(k) K240993

Device
encevis (2.1)
Applicant
Ait Austrian Institute of Technology GmbH
510(k) number
K240993
Product code
OMB
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-27
Date received
2024-04-11
Regulation
882.1400
Classification name
Automatic Event Detection Software For Full-Montage Electroencephalograph
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tilmann Kluge
Address
Giefinggasse 4 Vienna AT 1210 1210

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K200878Natus NeuroWorksNatus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)2020-05-18
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K182181Persyst 14 EEG Review and Analysis SoftwarePersyst Development Corporation2018-11-29