BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CODONICS SAFE LABELING SYSTEM (SLS) SLS-500i/550i/600i, SLS-500P, SLS-XXX, Point of Care Station (PCS)

    Reg #: 1530958 · FEI: 1000639866 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    CODONICS, INC.
    Registration Number
    1530958
    FEI Number
    1000639866
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    17991 Englewood Dr
    City
    Middleburg Heights
    State
    OH
    ZIP
    44130
    Country
    US

    Regulatory Submissions

    510(k) Number
    K101439

    Owner / Operator

    Firm Name
    CODONICS, INC.
    Operator Number
    9026554
    Address
    17991 ENGLEWOOD DR., --
    City
    Middleburg Heights
    State
    OH
    Postal Code
    44130
    Country
    US
    Correspondent
    Vincent - Yee

    Products

    Device Name Product Code
    Gas-Machine, Anesthesia BSZ

    Proprietary Names

    CODONICS SAFE LABELING SYSTEM (SLS) SLS-500i/550i/600i, SLS-500P, SLS-XXX, Point of Care Station (PCS)

    Establishment Types

    Remanufacture Medical Device Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device