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510(k) Data Aggregation

    K Number
    K120577
    Device Name
    MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX
    Manufacturer
    MEDIKRO OY
    Date Cleared
    2015-06-24

    (1213 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIKRO OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medikro Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed for - . adult and pediatric patients, - hospital and clinic use only.
    Device Description
    Medikro® SpiroStar spirometer runs on a personal computer with Microsoft Windows operating systems. Medikro® SpiroStar spirometer unit is connected to PC via USB port (USB model) or via serial port (DX model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. A nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations. Medikro® SpiroStar spirometers are used to measure lung air volume and airflow rate. Medikro® Spirometry Software is used to perform the measurement and calculate the measurement volume based on chosen reference value. The reference value is based on patient's gender, race and age. User can analyze the results in different presentations and create a final report based on the results and patient information. The spirometers take all the power that it needs from the USB or serial port, so no other external or internal power supply is needed.
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    K Number
    K133428
    Device Name
    MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
    Manufacturer
    MEDIKRO OY
    Date Cleared
    2014-05-21

    (194 days)

    Product Code
    BZG
    Regulation Number
    868.1840
    Why did this record match?
    Applicant Name (Manufacturer) :

    MEDIKRO OY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Medikro® Spirometer is a device that measures lung air volume and airflow rate for pulmonary disease diagnosis and screening. These measurements provide information about a patient's pulmonary function which may be compared with normal values or the patient's previous values. The device is designed to test pulmonary function and obtain spirometric indices for - adult and pediatric patients 12 years and older, - hospital and clinic use only.
    Device Description
    Medikro® spirometer runs on a personal computer with Microsoft Windows operating systems. Medikro@ spirometer unit is connected to PC via USB port (USB model). SpiroSafe disposable flow transducer is connected to the spirometer unit via pressure tube. Nose clip is used to prevent air flow from nose during measurements. Optional calibration syringe is used for recommended daily volume calibrations. Medikro® spirometers are used to measure lung air volume and airflow rate. Medikro® Spirometry Software is used to perform the measurement and calculate the measurement volume based on chosen reference value. The reference value is based on patient's gender, race and age. User can analyze the results in different presentations and create a final report based on the results and patient information. The spirometers take all the power that it needs from the USB port, so no other external or internal power supply is needed.
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