Persyst 14 Review and Analysis Software

GUDID 00869732000128

Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring and trending of EEG recordings during acquisition and reviewing of processed recordings.

PERSYST DEVELOPMENT CORP

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• Primary Device ID: 00869732000128
• NIH Device Record Key: 15381ad2-5ba8-4f5e-8c90-14a425de47f8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Persyst 14 Review and Analysis Software
• Version Model Number: P14
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00869732000128 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182181

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

Devices Manufactured by PERSYST DEVELOPMENT CORP

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• 00869732000128 - Persyst 14 Review and Analysis Software: 2019-07-12 Persyst 14 is a quantitative EEG trending, spike and seizure detection software. Persyst 14 is used for both monitoring and tren
• 00869732000135 - Persyst Mobile App: 2019-07-12 This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system p
• 00869732000142 - Persyst Mobile App: 2019-07-12 This is an application intended to be used by neurologists who are monitoring or reviewing EEGs. It is part of a larger system p
• 00869732000104 - Persyst 12 EEG Review and Analysis Software: 2019-07-12 Persyst 12 is a quantitative EEG trending, spike and seizure detection software. Persyst 12 is used for both monitoring and tren
• 00869732000111 - Persyst 13 EEG Review and Analysis Software: 2019-07-12 Persyst 13 is a quantitative EEG trending, spike and seizure detection software. Persyst 13 is used for both monitoring and tren