PERSYST DEVELOPMENT LLC

FDA Device Registration & Listing · Solana Beach, CA, US · Registration 2031720

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2031720
FEI Number
3002624053
Entity Name
PERSYST DEVELOPMENT LLC
City/State/Country
Solana Beach, CA, US
Establishment Address
420 Stevens Avenue, Suite 210, Solana Beach, CA 92075, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device
Owner / Operator
PERSYST DEVELOPMENT LLC (Owner Number: 9014025)
Owner / Operator Contact Address
420 Stevens Avenue, SUITE 210, Solana Beach, CA 92075, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K242446
PMA Number
N/A

All Registered Proprietary Names

Persyst ESI powered by Epilog (Persyst Electrical Source Imaging) Persyst 13 (P13)EEG REVIEW AND ANALYSIS SOFTWARE PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE Persyst Mobile App Persyst 14 EEG Review and Analysis Software (P14) Persyst 15 EEG Review and Analysis Software

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph Neurology Class 2 882.1400 2020-09-02
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2015-08-25
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2015-08-25
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2015-08-25
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2014-06-23
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2014-06-23
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2014-06-23
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2017-10-09
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2017-10-09
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2017-10-09
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2018-12-03
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2018-12-03
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2018-12-03
OMA Amplitude-Integrated Electroencephalograph Neurology Class 2 882.1400 2025-03-04
OLX Source Localization Software For Electroencephalograph Or Magnetoencephalograph Neurology Class 2 882.1400 2025-03-04
OLT Non-Normalizing Quantitative Electroencephalograph Software Neurology Class 2 882.1400 2025-03-04
OMB Automatic Event Detection Software For Full-Montage Electroencephalograph Neurology Class 2 882.1400 2025-03-04

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PERSYST DEVELOPMENT LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K033010 Brainz Instruments , Ltd. BRM2 BRAIN MONITOR 2003-10-10
K991012 Siemens Medical Solutions USA, Inc. SIEMENS INFINITY EEG POD 1999-06-24
K852587 Tracor Northern, Inc. CDSA(COLOR DENSITY, SPECTRAL ARRRAY) 1985-08-16

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031720. Last updated year: 2026. Please use registration number 2031720 when referencing this establishment in official correspondence.
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