Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9617286

FEI Number

3003208775

Entity Name

EB NEURO, S.P.A.

City/State/Country

FLORENCE Tuscany, IT

Establishment Address

VIA PIETRO FANFANI 97/A, FLORENCE Tuscany 50127, IT

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

EB NEURO, S.P.A. (Owner Number: 9043444)

Owner / Operator Contact Address

VIA PIETRO FANFANI 97/A, --, FLORENCE, IT-NOTA 50127, IT

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K242305

PMA Number

N/A

All Registered Proprietary Names

BE MICRO Trea BE Plus PRO Neurotravel LIGHT

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2010-07-12
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2010-07-12
MNR	Ventilatory Effort Recorder	Anesthesiology	Class 2	868.2375	2010-07-12
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2010-07-12
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2010-07-12
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2024-11-20
GWL	Amplifier, Physiological Signal	Neurology	Class 2	882.1835	2024-11-20
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	Class 2	882.1400	2024-11-20
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	Class 2	882.1400	2024-11-20

Official Correspondent

Christiano Pineider

US Agent Details

Silvia Tamarri Business: THEMA CORP Email: usreg@complifegroup.com Phone: (215) 8459459

Related Public Records

Same Entity

EB NEURO, S.P.A.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3001687738	EB NEURO S.P.A.	Arbizzano di Valpolicella Verona, IT

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K082968	Apneicare, LLC	APNEICARE CONNECTION CENTER/INTERNET ANALYSIS	2009-01-02
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2008	Bio-Logic Systems Corp	2	Bio-logic System Corp --Telescoping Camera Pole Assembly (part number 585-CYBPSM and 580-VIDPOL) and assemblies (580IPCART and 580 PNCART; Bio-Logic Systems Corporation, Mundelein, IL 60060; The Model 580-VIDPOL is used with the 580-PNCART that is wired for use with a Panasonic Camera. The pole is also a subassembly of the 585-CYBPSM with wires used in the 580-IPCART wired for the use with an Ipela Camera. Both carts are a component of the Ceegraph/Sleepscan Netlink with Video.
Z-0031-2022	NOX MEDICAL Keldnaholt Reykjavik Iceland	2	Nox T3s Recorder - Product Usage: intended for ambulatory recording of physiological signals during sleep.
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9617286. Last updated year: 2026. Please use registration number 9617286 when referencing this establishment in official correspondence.