BEUDAMED
    FDA Registration Active 🇺🇸 United States

    PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE

    Reg #: 2031720 · FEI: 3002624053 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    3

    Registration Details

    Registration Name
    PERSYST DEVELOPMENT LLC
    Registration Number
    2031720
    FEI Number
    3002624053
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    420 Stevens Avenue, Suite 210
    City
    Solana Beach
    State
    CA
    ZIP
    92075
    Country
    US

    Regulatory Submissions

    510(k) Number
    K133793

    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
    Automatic Event Detection Software For Full-Montage Electroencephalograph OMB
    Non-Normalizing Quantitative Electroencephalograph Software OLT
    Amplitude-Integrated Electroencephalograph OMA

    Proprietary Names

    PERSYST 12 ( P12) EGG REVIEW AND ANALYSIS SOFTWARE

    Establishment Types

    Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198