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510(k) Data Aggregation
K Number
K120577Device 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
868.1840Why 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
K133428Device Name
MEDIKRO NANO, MEDIKRO PRIMO AND MEDIKRO PRO
Manufacturer
MEDIKRO OY
Date Cleared
2014-05-21
(194 days)
Product Code
BZG
Regulation Number
868.1840Why 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.
Ask a Question
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