Component Neuromonitoring System

GUDID B485CNS3201

International (non-U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from mul

MOBERG RESEARCH INC

Electroencephalographic monitoring system, portable Electroencephalographic monitoring system, portable Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system Electroencephalographic monitoring system

• Primary Device ID: B485CNS3201
• NIH Device Record Key: fae4cdb5-d533-4b38-b011-47094d547578
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Component Neuromonitoring System
• Version Model Number: CNS-320
• Company DUNS: 029957656
• Company Name: MOBERG RESEARCH INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B485CNS3201 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K080217

FDA Product Code

• GWQ: Full-Montage Standard Electroencephalograph

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-12-21

On-Brand Devices [Component Neuromonitoring System]

• B485CNSPTZ3101: Research model; optional camera that can be used to record video of the patient.
• B485CNSPTZ3001: Domestic (U.S.) model; optional camera that can be used to record video of the patient.
• B485CNSVID3201: International (non-U.S.) model; optional camera that can be used to record video of the patient.
• B485CNSVID3101: Research model; optional camera that can be used to record video of the patient.
• B485CNSVID3001: Domestic (U.S.) model; optional camera that can be used to record video of the patient.
• B485CNSINX3201: International (non-U.S.) model; 4 port isolated USB serial adapter
• B485CNSINX3101: Research model; 4 port isolated USB serial adapter
• B485CNSINX3001: Domestic (U.S.) model; 4 port isolated USB serial adapter
• B485CNSEEG3201: International (non-U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and
• B485CNSEEG3101: Research model; optional 40 input EEG amplifier for direct recording of EEG and other physiologi
• B485CNSEEG3001: Domestic (U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and other phy
• B485CNSEEG2201: International (non-U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and
• B485CNSEEG2101: Research model; optional 16 input EEG amplifier for direct recording of EEG and other physiologi
• B485CNSEEG2001: Domestic (U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and other phy
• B485CNS3201: International (non-U.S.) model; a portable, computer-based system that can continuously record,
• B485CNS3101: Research model; a portable, computer-based system that can continuously record, display, store a
• B485CNS3001: Domestic (U.S.) model; a portable, computer-based system that can continuously record, display,
• B485CNS3501: A portable, computer-based system that can continuously record, display, store and analyze physi