BEUDAMED
    FDA Registration Active 🇫🇮 Finland

    M913, Medikro Nano Spirometer

    Reg #: 3006895489 · FEI: 3006895489 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    30
    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
    K133428

    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

    M913, Medikro Nano Spirometer M9227-100, Nose clip, 100 pieces M9256-50, Disposable Flow Transducer, 50 pieces M974, Medikro Primo Spirometer Starter System M973, Medikro Nano Spirometer Starter System M915, Medikro Pro Spirometer M9256-100, Disposable Flow Transducer, 100 pieces M914, Medikro Primo Spirometer M9256-SP-45, Disposable Flow Transducer, single packed 45 pieces M983+911, Medikro Nano Spirometer with Starter Consumable Pack and Medikro Ambi M985, Medikro Pro Spirometer with Starter Consumable Pack M983, Medikro Nano Spirometer with Starter Consumable Pack M9274, Pressure Tube with grip for SpiroSafe flow transducer 720708, WELCH ALLYN USB DATA CABLE M9264-200, Pressure Tube with connectors for Flow Transducer, length 200 cm M973+911, Medikro Nano Spirometer Starter System with Medikro Ambi M91227-25, Grip for SpiroSafe flow transducer, single packed 25 pieces M9256-SP-90, Disposable Flow Transducer, single packed 90 pieces M984, Medikro Primo Spirometer with Starter Consumable Pack M911, Medikro Ambi Ambient Measurement Unit 720706, FLOW TRANSDUCERS, SPIRO, 100 PK M9474, Calibration Syringe, volume 3000 ml 725800, FLOW TRANSDUCERS, SPIRO, 4 PK 410027, SPIROMETRY KIT, CP150 M975, Medikro Pro Spirometer Starter System 410370, PRESSURE TUBE & HANDLE, SPIRO 720705, FLOW TRANSDUCERS, SPIRO, 25 PK 720854, NOSE CLIP 410857, SPIROMETER KIT FOR CONNEX CARDIO 722444, WELCH ALLYN USB DATA CABLE 1.8M

    Establishment Types

    Manufacture Medical Device