Persyst Mobile App

GUDID 00869732000142

This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system provided by Persyst.

PERSYST DEVELOPMENT CORP

Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software Bioelectrical signal analysis software

• Primary Device ID: 00869732000142
• NIH Device Record Key: 47d51dff-a409-4e89-997f-936ad663a803
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persyst Mobile App
• Version Model Number: App for Web
• Company DUNS: 024168209
• Company Name: PERSYST DEVELOPMENT CORP
• 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

Customer Support Contacts

• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com
• Phone: 19287080705
• Email: support@persyst.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869732000142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171184

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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-07-12
• Device Publish Date: 2019-04-08

On-Brand Devices [Persyst Mobile App]

• 00869732000142: This is an application intended to be used by neurologists who are monitoring or reviewing EEGs.
• 00869732000135: This is an application intended to be used by neurologists who are monitoring or reviewing EEGs.