Galileo NT Line Software

Basic Information

• Brand Name: Galileo NT Line Software
• Primary DI: 08056446900642
• Version / Model: B8640053000
• Company Name: EB NEURO SPA
• Labeler DUNS: 339182263
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-25
• Public Version: 1
• Public Version Date: 2020-06-02
• Public Version Status: New
• Public Device Record Key: bdd6ca75-8c5a-445f-adda-22b303974d93

Device Description

Software for EEG, EMG, EP and other applications based on acquiring, processing and analyzing of biological electrical signals. Identifier (8012) contains the software version.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXE	Device, Nerve Conduction Velocity Measurement	Neurology	882.1550	2
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	882.1400	2
GWJ	Stimulator, Auditory, Evoked Response	Neurology	882.1900	2
GWE	Stimulator, Photic, Evoked Response	Neurology	882.1890	2
GWF	Stimulator, Electrical, Evoked Response	Neurology	882.1870	2
IKN	Electromyograph, Diagnostic	Physical Medicine	890.1375	2
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
47541	Bioelectrical signal analysis software	A software program intended to acquire, process, store and analyse biological electrical signals, both in real-time and delayed time, for diagnostic applications. The signals are typically provided by electrophysiological recording/monitoring [e.g., electromyography (EMG), electroencephalography (EEG), evoked potentials (EP), bioelectrical impedance analysis (BIA)]. It may be installed in the recording/monitoring device, personal computer, or data network server. It is neither intended for continuous bedside nor intraoperative monitoring, and is not dedicated to hearing analysis.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08056446900642	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K142064	000