Component Neuromonitoring System

Basic Information

• Brand Name: Component Neuromonitoring System
• Primary DI: B485CNS3001
• Version / Model: CNS-300
• Company Name: MOBERG RESEARCH INC
• Labeler DUNS: 029957656
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-12-21
• Public Version: 4
• Public Version Date: 2022-11-28
• Public Version Status: Update
• Public Device Record Key: adfa36b9-1928-4eda-9f43-8b1f8fb654b0

Device Description

Domestic (U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
GWQ	Full-Montage Standard Electroencephalograph	Neurology	882.1400	2
ORT	Burst Suppression Detection Software For Electroencephalograph	Neurology	882.1400	2
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	870.1025	2
OMA	Amplitude-Integrated Electroencephalograph	Neurology	882.1400	2
MUD	Oximeter, Tissue Saturation	Cardiovascular	870.2700	2
OLT	Non-Normalizing Quantitative Electroencephalograph Software	Neurology	882.1400	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38736	Electroencephalographic monitoring system	An electrically-powered device assembly designed to continuously measure the electrical signals produced by a patient's brain and display/record them as an electroencephalogram (EEG) to evaluate brain function, typically in an examination room or intensive care unit (ICU) [bedside]; it may also monitor additional physiological parameters [e.g., electromyogram (EMG), respiration wave forms, blood pressure, haemoglobin oxygen saturation (SpO2)] in relation to EEG. It typically includes a control unit, electrodes, and components (e.g., amplifier, cables, probes). It may include data interpretation and/or telemetry features.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B485CNS3001	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K080217	000