BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Stealth System S300

    Reg #: 3010342616 · FEI: 3010342616 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    3
    Classifications
    2

    Registration Details

    Registration Name
    CARDIAC INSIGHT, INC.
    Registration Number
    3010342616
    FEI Number
    3010342616
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    2375 130th Ave NE, Suite 101
    City
    Bellevue
    State
    WA
    ZIP
    98005
    Country
    US

    Regulatory Submissions

    510(k) Number
    K162503

    Owner / Operator

    Firm Name
    Cardiac Insight, Inc.
    Operator Number
    10044470
    Address
    2375 130th Ave NE, Suite 101
    City
    Bellevue
    State
    WA
    Postal Code
    98005
    Country
    US
    Correspondent
    Daniel J Tylutki

    Products

    Device Name Product Code
    Recorder, Magnetic Tape, Medical DSH
    Computer, Diagnostic, Programmable DQK

    Proprietary Names

    Stealth System S300 Cardea SOLO

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility Manufacture Medical Device