Live View Panel Version 1.3

Basic Information

• Brand Name: Live View Panel Version 1.3
• Primary DI: 00817111020786
• Version / Model: 1.3
• Company Name: Neurotronics, LLC
• Labeler DUNS: 036405363
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-22
• Public Version: 7
• Public Version Date: 2023-04-14
• Public Version Status: Update
• Public Device Record Key: ca2333e4-44cb-4dd4-af3d-39862c6bce9a

Device Description

Live View Panel Version 1.3

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: Yes
• 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
OLZ	Automatic Event Detection Software For Polysomnograph With Electroencephalograph	Neurology	882.1400	2
OLV	Standard Polysomnograph With Electroencephalograph	Neurology	882.1400	2
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	882.1400	2
GWQ	Full-Montage Standard Electroencephalograph	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
42238	Sleep disorder interpretive software	An interpretive software program intended to collect and analyse patient physiological data during sleep and publish reports to assist a healthcare professional in the diagnosis of sleep disorders (e.g., insomnia, snoring, sleep apnoea) or to help evaluate treatment (e.g., positive airway pressure). It may be used as part of a complete polysomnography study using a wide range of data (e.g., electrocardiogram (ECG), electroencephalogram (EEG), haemoglobin oxygen saturation (SpO2), chest wall motion, airflow, eye movement), or as part of a home-based study using a more limited data set [e.g., photoplethysmography (PPG) and motion tracking].	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817111020786	GS1

Premarket Submissions

Submission Number	Supplement Number
K131415	000