BEUDAMED
    FDA Registration Active 🇺🇸 United States

    CIRRUS HD-OCT 500

    Reg #: 2918630 · FEI: 2918630 · Expires 2025
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    CARL ZEISS MEDITEC INC
    Registration Number
    2918630
    FEI Number
    2918630
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    5300 Central Parkway
    City
    DUBLIN
    State
    CA
    ZIP
    94568
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181534

    Owner / Operator

    Firm Name
    Carl Zeiss Meditec, Inc.
    Operator Number
    9053564
    Address
    5300 Central Parkway
    City
    Dublin
    State
    CA
    Postal Code
    94568
    Country
    US
    Correspondent
    Paul Swift

    Products

    Device Name Product Code
    Tomography, Optical Coherence OBO
    System, Imaging, Pulsed Echo, Ultrasonic IYO
    Transducer, Ultrasonic, Diagnostic ITX

    Proprietary Names

    CIRRUS HD-OCT 500 CIRRUS HD-OCT 5000

    Establishment Types

    Manufacture Medical Device