encevis

GUDID 09120109830122

encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.

AIT Austrian Institute of Technology GmbH

Bioelectrical signal analysis software

• Primary Device ID: 09120109830122
• NIH Device Record Key: 72ee4f05-da6b-4441-96e4-1048522a2b30
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: encevis
• Version Model Number: 1.12
• Company DUNS: 300281748
• Company Name: AIT Austrian Institute of Technology GmbH
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120109830122 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211452

FDA Product Code

• OMB: Automatic Event Detection Software For Full-Montage 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: 2022-07-25
• Device Publish Date: 2022-07-15

On-Brand Devices [encevis]

• 09120109830078: encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used fo
• 09120109830122: encevis is a quantitative EEG trending, spike and seizure detection software. encevis is used fo
• 09120109830269: encevis is a quantitative EEG trending, spike, seizure and status epilepticus detection software