Neuron-Spectrum

GUDID 04650075333211

The digital systems CloudEEG are intended for use as digital neurophysiological systems intended for recording, processing and display biopotential signals such as Electroencephalography (EEG) and long-latency Evoked Potential (EP). Polysomnography (PSG) derives from Electroencephalography (EEG) by the means of a dedicated software module and dedicated electrodes. The devices are portable and can register up to 19 EEG channels, 1 polygraphic channel and 1 breath channel. The devices do not provide alarms, do not provide automated event marking and do not provide to the user any diagnostic conclusion about the patient's condition. They are intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals experimental laboratories and sleep laboratories. The patient group includes all ages and sexes.

NEUROSOFT, OOO

Electroencephalograph

• Primary Device ID: 04650075333211
• NIH Device Record Key: 6b3d49e2-8ad2-4f28-a30d-33f77c3fc66b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neuron-Spectrum
• Version Model Number: CloudEEG
• Company DUNS: 643212926
• Company Name: NEUROSOFT, OOO
• 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: false
• 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

Customer Support Contacts

• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com
• Phone: 617 8403253
• Email: Jjabre@teleemg.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	04650075333211 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K133995

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: 2021-07-30
• Device Publish Date: 2021-07-22

On-Brand Devices [Neuron-Spectrum]

• 04650075330135: The digital systems Neuron-Spectrum- 4/P are intended for use as digital neurophysiological sys
• 04650075330128: The digital systems Neuron-Spectrum-4 are intended for use as digital neurophysiological system
• 04650075330111: The digital systems Neuron-Spectrum-3 are intended for use as digital neurophysiological system
• 04650075330104: The digital systems Neuron-Spectrum-2 are intended for use as digital neurophysiological system
• 04650075330098: The digital systems Neuron-Spectrum-1 are intended for use as digital neurophysiological system
• 04650075333211: The digital systems CloudEEG are intended for use as digital neurophysiological systems intende