Persyst Mobile App

GUDID 00869732000135

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

• Primary Device ID: 00869732000135
• NIH Device Record Key: d9a400c7-cdd4-4ab4-942f-6186f8abc6ef
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persyst Mobile App
• Version Model Number: App for iOS
• 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
• 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	00869732000135 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171184

FDA Product Code

• OLT: Non-Normalizing Quantitative Electroencephalograph Software

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.