Esprit Nova

GUDID 00627987257502

Esprit Nova is a software application that analyzes previously recorded physiological signals obtained during sleep.

Neurozone MSH Inc

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• Primary Device ID: 00627987257502
• NIH Device Record Key: 708af24f-20ca-493a-937c-38d1f4b70992
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Esprit Nova
• Version Model Number: v 1.1
• Company DUNS: 203746532
• Company Name: Neurozone MSH 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627987257502 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182227

FDA Product Code

• OLZ: Automatic Event Detection Software For Polysomnograph With 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: 2020-12-14
• Device Publish Date: 2020-12-06