Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017374042

FEI Number

3017374042

Entity Name

AIT AUSTRIAN INSTITUTE OF TECHNOLOGY GMBH

City/State/Country

Vienna Wien, AT

Establishment Address

Giefingasse 4, Vienna Wien 1210, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AIT Austrian Institute of Technology GmbH (Owner Number: 10077267)

Owner / Operator Contact Address

Giefingasse 4, Vienna, AT-9 1210, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K171720

PMA Number

N/A

All Registered Proprietary Names

encevis 2.1 encevis encevis

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2024-11-27
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2024-11-27
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	Class 2	882.1400	2024-11-27
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2022-06-27
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2022-06-27
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	Class 2	882.1400	2022-06-27
OMA	Amplitude-Integrated Electroencephalograph	Neurology	Class 2	882.1400	2020-08-19
OMB	Automatic Event Detection Software For Full-Montage Electroencephalograph	Neurology	Class 2	882.1400	2020-08-19
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-08-19

Official Correspondent

Sandra Simhofer

US Agent Details

Rhonda Alexander Business: IUVO Consulting, LLC Email: ralexander@iuvoconsulting.com Phone: (202) 7928344

Related Public Records

Same Entity

AIT Austrian Institute of Technology GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033010	Brainz Instruments , Ltd.	BRM2 BRAIN MONITOR	2003-10-10
K991012	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY EEG POD	1999-06-24
K852587	Tracor Northern, Inc.	CDSA(COLOR DENSITY, SPECTRAL ARRRAY)	1985-08-16

Similar Registrations

Registration Number	Establishment Name	Location
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
9611252	NIHON KOHDEN CORP.	SHINJUKU-KU Tokyo, JP
3010611950	Natus Neurology Incorporated	Middleton, WI, US
9612330	NATUS MEDICAL INCORPORATED DBA EXCEL-TECH LTD. (XLTEK)	OAKVILLE Ontario, CA
8030229	NIHON KOHDEN TOMIOKA PRODUCTION CENTER	TOMIOKA-SHI Gunma, JP

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017374042. Last updated year: 2026. Please use registration number 3017374042 when referencing this establishment in official correspondence.