BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Spacelabs 90207 / 90217A Ambulatory BLood Presure Monitor

    Reg #: 3010082909 · FEI: 3010082909 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    Emsere, Inc.
    Registration Number
    3010082909
    FEI Number
    3010082909
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    627 Highway 74 South, Suite 220
    City
    Peachtree City
    State
    GA
    ZIP
    30269
    Country
    US

    Regulatory Submissions

    510(k) Number
    K103732

    Owner / Operator

    Firm Name
    Emsere, Inc
    Operator Number
    10047331
    Address
    Zaalbergweg 9
    City
    Leiden
    State
    Zuid-Holland
    Postal Code
    2314XS
    Country
    NL

    Products

    Device Name Product Code
    System, Measurement, Blood-Pressure, Non-Invasive DXN

    Proprietary Names

    Spacelabs 90207 / 90217A Ambulatory BLood Presure Monitor

    Establishment Types

    Repack or Relabel Medical Device