Component Monitoring System

GUDID B485CNSVID3501

Domestic model; optional camera that can be used to record video of the patient.

MOBERG RESEARCH INC

Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera Multi-purpose digital medical camera

• Primary Device ID: B485CNSVID3501
• NIH Device Record Key: 71a51d10-fe79-486d-a558-acfee191d9c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Component Monitoring System
• Version Model Number: CNS-VID-350
• 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	B485CNSVID3501 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-09
• Device Publish Date: 2020-10-31

On-Brand Devices [Component Monitoring System]

• B485CNSVID3701: International model; optional camera that can be used to record video of the patient.
• B485CNSVID3501: Domestic model; optional camera that can be used to record video of the patient.
• B485CNSPTZ3501: Optional camera that can be used to record video of the patient.