BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PERSYST DEVELOPMENT LLC

    Reg #: 2031720 · FEI: 3002624053 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    4

    Registration Details

    Registration Name
    PERSYST DEVELOPMENT LLC
    Registration Number
    2031720
    FEI Number
    3002624053
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    420 Stevens Avenue, Suite 210
    City
    Solana Beach
    State
    CA
    ZIP
    92075
    Country
    US

    Regulatory Submissions

    510(k) Number
    K172858

    Owner / Operator

    Firm Name
    PERSYST DEVELOPMENT LLC
    Operator Number
    9014025
    Address
    420 Stevens Avenue, SUITE 210
    City
    Solana Beach
    State
    CA
    Postal Code
    92075
    Country
    US

    Products

    Device Name Product Code
    Source Localization Software For Electroencephalograph Or Magnetoencephalograph OLX
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Amplitude-Integrated Electroencephalograph OMA
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB

    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

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device