Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008008477

FEI Number

3008008477

Entity Name

G.TEC MEDICAL ENGINEERING GMBH

City/State/Country

Graz Steiermark, AT

Establishment Address

Herbersteinstrasse 60, Graz Steiermark 8020, AT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

G.TEC MEDICAL ENGINEERING GMBH (Owner Number: 9084852)

Owner / Operator Contact Address

14 SIERNINGSTRASSE, --, SCHIEDLBERG, AT-NOTA 4521, AT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K173684

PMA Number

N/A

All Registered Proprietary Names

cortiQ PRO g.Nautilus PRO g.ESTIM FES g.Estim PRO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-05
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2020-03-05
OLU	Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2020-03-05
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2017-08-03
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2017-08-03
IPF	Stimulator, Muscle, Powered	Physical Medicine	Class 2	890.5850	2020-11-27
GZI	Stimulator, Neuromuscular, External Functional	Neurology	Class 2	882.5810	2020-11-27
GYC	Electrode, Cortical	Neurology	Class 2	882.1310	2018-05-11

Official Correspondent

CHRISTOPH GUGER

US Agent Details

Peter Hasslacher Email: newyork@wko.at Phone: (212) 4215250

Related Public Records

Same Entity

G.TEC MEDICAL ENGINEERING GMBH

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3005713796	G.TEC MEDICAL ENGINEERING GMBH	SCHIEDLBERG Oberosterreich, AT

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
K070612	Top-Rank Health Care Equipment Co., Ltd.	TOP-RANK ADHESIVE ELECTRODE	2007-05-07
K123915	Grass Technologies, an Astro-Med, Inc. Product Gro	DE48-PLUS	2013-04-24

Similar Registrations

Registration Number	Establishment Name	Location
3038281851	Philips Polska Sp. z o.o.	Lodz Lodzkie, PL
3016852448	Nihon Kohden Corporation - Eastern Japan Logistics Center	Sakado City Saitama, JP
3008773490	PAUL E. DANCHELL A/S	Jyderup Sjalland, DK
9611252	NIHON KOHDEN CORP.	SHINJUKU-KU Tokyo, JP
3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008008477. Last updated year: 2026. Please use registration number 3008008477 when referencing this establishment in official correspondence.