BEUDAMED
    FDA Registration Active 🇹🇼 Taiwan

    VersalVent V1 Hyperbaric Ventilator

    Reg #: 3004127991 · FEI: 3004127991 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    PAN-AMERICA HYPERBARICS, INC.
    Registration Number
    3004127991
    FEI Number
    3004127991
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    4F No. 329, LONG JIANG ROAD, JHONG SHAN DISTRICT
    City
    TAIPEI CITY
    Country
    TW

    Regulatory Submissions

    510(k) Number
    K122560

    Owner / Operator

    Firm Name
    PAN-AMERICA HYPERBARICS, INC.
    Operator Number
    9051324
    Address
    4F No. 329, LONG JIANG ROAD, JHONG SHAN DISTRICT
    City
    TAIPEI CITY
    State
    TW-NOTA
    Postal Code
    10476
    Country
    TW
    Correspondent
    CHI-SHENG - TSAI

    US Agent

    Business Name
    Pan-America Hyperbarics, Inc.
    Contact Name
    Shin Ban Tsai
    Address
    1607 Capital Ave
    City
    Plano
    State
    TX
    ZIP
    75074
    Country
    US
    Email
    [email protected]
    Phone
    972 4230377

    Products

    Device Name Product Code
    Ventilator, Continuous, Facility Use CBK

    Proprietary Names

    VersalVent V1 Hyperbaric Ventilator

    Establishment Types

    Manufacture Medical Device