BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    M921 Medikro® SpiroStar DX

    Reg #: 3006895489 · FEI: 3006895489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    9
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    MEDIKRO OY
    Registration Number
    3006895489
    FEI Number
    3006895489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Pioneerinkatu 3
    City
    Kuopio Pohjois-Savo
    Country
    FI

    Regulatory Submissions

    510(k) Number
    K120577

    Owner / Operator

    Firm Name
    Medikro Oy
    Operator Number
    10047101
    Address
    Pioneerinkatu 3
    City
    Kuopio
    State
    FI-NOTA
    Postal Code
    FI-70800
    Country
    FI
    Correspondent
    Mikko Hintikka

    US Agent

    Business Name
    Quality & Regulatory Services, Inc.
    Contact Name
    Robert Morton
    Address
    1244 Fairway Valley Ct
    City
    Lincoln
    State
    CA
    ZIP
    95648
    Country
    US
    Email
    [email protected]
    Phone
    925 7872421

    Products

    Device Name Product Code
    Spirometer, Diagnostic BZG

    Proprietary Names

    M921 Medikro® SpiroStar DX M929 Medikro® SpiroStar USB 703419 Disposable Flow Transducers QTY 100 M9242-SP-90, SpiroSafe Disposable Flow Transducer M9242-100, SpiroSafe Disposable Flow Transducer 703554 Spirometer Kit (USB) 703552 Spirometer Kit (Serial) 703417 Disposable Flow Transducers QTY 4 703418 Disposable Flow Transducers QTY 25

    Establishment Types

    Manufacture Medical Device