BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    SpiroSphere

    Reg #: 3008505660 · FEI: 3008505660 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    3
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    eResearchTechnology GmbH
    Registration Number
    3008505660
    FEI Number
    3008505660
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Sieboldstrasse 3
    City
    Estenfeld Bavaria
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K223629

    Owner / Operator

    Firm Name
    eResearch Technology
    Operator Number
    10026366
    Address
    1818 Market Street, Suite 2600
    City
    Philadelphia
    State
    PA
    Postal Code
    19103
    Country
    US
    Correspondent
    Todd Kisner

    US Agent

    Business Name
    ERESEARCH TECHNOLOGY
    Contact Name
    Todd Kisner
    Address
    1818 Market Street, Suite 2600
    City
    Philadelphia
    State
    PA
    ZIP
    19103
    Country
    US
    Email
    [email protected]
    Phone
    609 9364594

    Products

    Device Name Product Code
    Calculator, Predicted Values, Pulmonary Function BTY
    Electrocardiograph DPS

    Proprietary Names

    SpiroSphere CardioSphere SpiroSphere ECG

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device