BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SAFETYSPECT Inc

    Reg #: 3042025620 · FEI: 3042025620 · Expires 2026
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

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    Registration Details

    Registration Name
    SAFETYSPECT Inc
    Registration Number
    3042025620
    FEI Number
    3042025620
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    4200 James Ray Dr
    City
    Grand Forks
    State
    ND
    ZIP
    58202
    Country
    US

    Regulatory Submissions

    510(k) Number
    K161237

    Owner / Operator

    Firm Name
    SafetySpect
    Operator Number
    10094214
    Address
    4200 James Ray Dr
    City
    Grand Forks
    State
    ND
    Postal Code
    58202
    Country
    US
    Correspondent
    Dan Newman

    Products

    Device Name Product Code
    Oximeter, Tissue Saturation MUD
    Medical Device Data System OUG

    Proprietary Names

    HyperView SafetySpect MDDS System

    Establishment Types

    Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility