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Found 10 results
510(k) Data Aggregation
K Number
K130784Device Name
SPIROTEL
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2013-10-30
(223 days)
Product Code
BZG, DQA
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a singlepatient device and can be used in any setting - home, factory, pharmacy, hospital or physician's office.
Device Description
Spirotel is a pocket spirometer that can also feature a pulse oximeter function (optional). It measures a range of functional respiratory parameters, and the oxygen saturation and pulse rate. The device can operate completely autonomously or can be connected to a personal computer by means of various types of connections: USB, Bluetooth, GSM.
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K Number
K122384Device Name
MINISPIR
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2012-10-04
(59 days)
Product Code
BZG, BZQ, DQA
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Minispir and Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make: - spirometry testing in people of all ages, excluding infants and neonates. . - oximetry testing in people of all ages. ● They can be used in any setting.
Device Description
Minispir is a spirometer and pulse oximeter (optional) connected to a Personal Computer using a USB cable. The device measures a range of respiratory parameters, and the saturation of oxygen in the blood and the heart pulse rate.
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K Number
K081033Device Name
MIROXI
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2009-01-15
(279 days)
Product Code
DQA
Regulation Number
870.2700Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIROxi pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test oximetry in people of all ages.
It can be used in any setting.
Device Description
MIROxi is a pulse oximeter, designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 statistical parameters derived from the SpO2 and pulse rate.
Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
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K Number
K082766Device Name
MODIFICATION TO MINISPIR, SPIROLAB III
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2008-12-17
(86 days)
Product Code
BZG, DQA
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIR Minispir - Spirolab III spirometers and pulse oximeters are intended to be used by either a physician, respiratory therapist or technician.
The devices are intended to test lung function and can make:
- spirometry testing in people of all ages, excluding infants and neonates.
- oximetry testing in people of all ages.
They can be used in any setting.
Device Description
MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Minispir - Spirolab III with their integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Minispir - Spirolab III calculate several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.
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K Number
K072979Device Name
SPIROBANK G
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2007-12-26
(65 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirobank G spirometer is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make spirometry testing in people of all ages, excluding infants and neonates. It can be used in any setting.
Device Description
Spirobank G is a spirometer designed to facilitate the total valuation of lung function. It is designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 spirometric parameters. Its connectivity capability (USB, Bluetooth) makes it suitable also for telemedicine applications.
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K Number
K061875Device Name
MINISPIR; SPIROLAB III
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2006-12-11
(161 days)
Product Code
BZG, DQA
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The MIR Minispir spirometer and Spirolab III spirometer and pulse oximeter are intended to be used by either a physician, respiratory therapist or technician. The devices are intended to test lung function and can make:
- spirometry testing in people of all ages, excluding infants and neonates .
- oximetry testing in people of all ages. .
They can be used in any setting.
Device Description
MIR Minispir - Spirolab III are instruments for the analysis of respiratory function, which carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with a calculation of the main spirometric parameters, predicted values and percentage deviations compared to the measured values. Plus Flow/Volume and Volume/time curves and the interpretation of the FVC test following the international spirometry standards (ATS/ERS). What is more Spirolab III with its integrated oximetry option, can calculate both Oxygen Saturation (expressed as %SpO2) and Pulse Rate (expressed as Beats Per Minutes- BPM). In additon Spirolab III calculates several (up to 20) additional statistical parameters derived from the SpO2 and the pulse rate.
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K Number
K061712Device Name
SPIROBANK II
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2006-12-01
(165 days)
Product Code
BZG, DQA
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirobank II spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic. The device is intended to test lung function and can make:
- spirometry testing in people of all ages, excluding infants and neonates .
- oximetry testing in people of all ages. .
It can be used in any setting.
Device Description
MIR Spirobank II is a spirometer and pulse oximeter, designed to facilitate the total valuation of lung function. It is designed for use by specialist who require a simple, portable and compact device, yet at the same time being capable of calculating more than 30 spirometric parameters, and monitors the oxygen saturation and pulse rate. It also calculates several additional statistical parameters derived from the SpO2 and the pulse rate. Its connectivity capability (USB, Bluetooth, internal modem for acoustic coupling to telephone, RS232) makes it suitable also for telemedicine applications.
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K Number
K052140Device Name
SPIROLAB, SPIROLAB II
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2006-03-16
(220 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirolab and Spirolab II spirometers are intended to be used by either a physician, respiratory therapist or technician to test lung function in people of all ages excluding infants and neonates. They can be used in any setting.
Device Description
The device carries out three different spirometric tests, FVC, VC(insp/exp) and MVV, with predicted values and percentage deviations calculation of the main parameters plus Flow/Volume and Volume/time curves and the interpretation of the measured values following the international spirometry standards (ATS/ERS).
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K Number
K043528Device Name
SPIROTEL
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
2005-07-19
(210 days)
Product Code
BZG, DQA
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Spirotel spirometer and pulse oximeter is intended to be used by a physician or by a patient under the instruction of a physician or paramedic to test lung function in people of all ages. It is also intended to be used as a single-patient device and can be used in any setting – home, factory, pharmacy, hospital or physician's office.
Device Description
MIR Spirotel is a simple to operate precise pocket spirometer and pulse oximeter (weight only 100g). It measures the most important functional respiratory parameters and monitors the oxygen saturation and pulse rate.
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K Number
K983909Device Name
MIR SPIROBANK SPIROMETER
Manufacturer
MIR MEDICAL INTL. RESEARCH SRL
Date Cleared
1998-12-21
(48 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
MIR MEDICAL INTL. RESEARCH SRL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device is a spirometer for lung-function testing. For testing lung-function in all people from children to adults, generally used by a physician or by a respiratory therapist or technician. Device is portable and thus can be used at home, in the factory, in the hospital, in the doctor's office.
Device Description
Device is a spirometer for lung-function testing. Device is portable.
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