DeepRESP

GUDID 15694311112099

Nox Medical ehf.

Sleep disorder interpretive software, professional-only

• Primary Device ID: 15694311112099
• NIH Device Record Key: 64875949-9edf-4b7e-b30c-48799135131b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DeepRESP
• Version Model Number: DEEPRESP
• Company DUNS: 365741462
• Company Name: Nox Medical ehf.
• 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: 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	15694311112099 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K241960

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: 2025-06-16
• Device Publish Date: 2025-06-06

Devices Manufactured by Nox Medical ehf.

• 15694311111191 - Nox SAS Body Cable - Right: 2025-06-16
• 15694311111207 - Nox SAS Body Cable - Left: 2025-06-16
• 15694311111214 - Nox SAS Head Cable: 2025-06-16
• 15694311112099 - DeepRESP: 2025-06-16
• 15694311112099 - DeepRESP: 2025-06-16
• 15694311112075 - Noxturnal Web: 2025-06-13
• 15694311112112 - Somryst: 2025-01-07
• 15694311111665 - Noxturnal US APP: 2021-10-26
• 15694311111610 - Nox A1® EEG 5 Lead Gold Electrode Cable: 2021-09-15