BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Apnea Risk Evaluation system Ares 610

    Reg #: 3008208119 · FEI: 3008208119 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WATERMARK MEDICAL Inc
    Registration Number
    3008208119
    FEI Number
    3008208119
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1117 Perimeter Ctr W Suite W514
    City
    Atlanta
    State
    GA
    ZIP
    30338
    Country
    US

    Regulatory Submissions

    510(k) Number
    K160499

    Owner / Operator

    Firm Name
    Watermark Medical Inc.
    Operator Number
    10030156
    Address
    1117 Perimeter Center West, Suite W514
    City
    Atlanta
    State
    GA
    Postal Code
    30338
    Country
    US
    Correspondent
    Carla Snyder

    Products

    Device Name Product Code
    Ventilatory Effort Recorder MNR

    Proprietary Names

    Apnea Risk Evaluation system Ares 610 Apnea Risk Evaluation system Ares 620

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility