BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SmartMonitor 2 Professional Series (PS)

    Reg #: 3006182632 · FEI: 3006182632 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    CIRCADIANCE
    Registration Number
    3006182632
    FEI Number
    3006182632
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    1010 Corporate Lane
    City
    Export
    State
    PA
    ZIP
    15632
    Country
    US

    Regulatory Submissions

    510(k) Number
    K032403

    Owner / Operator

    Firm Name
    Circadiance
    Operator Number
    10028090
    Address
    1010 Corporate Lane
    City
    Export
    State
    PA
    Postal Code
    15632
    Country
    US

    Products

    Device Name Product Code
    Monitor, Apnea, Home Use NPF
    Oximeter DQA

    Proprietary Names

    SmartMonitor 2 Professional Series (PS)

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility