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510(k) Data Aggregation
K Number
K100928Device Name
MICRO DIARY SPIROMETER
Manufacturer
VIASYS RESPIRATORY CARE INC.
Date Cleared
2011-03-07
(336 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
VIASYS RESPIRATORY CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Micro Diary Spirometer is used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs. Specifically, the Micro Diary Spirometer measures the following lung function parameters: FEV1, FVC, FEV6 and PEF. The device also records the test data for later review and has the ability to transfer these test records to a compatible computer.
Device Description
The Micro Diary Spirometer is a compact, hand held, and battery operated recording spirometer. The device features a five button keypad and an LCD display. The device utilizes a digital volume transducer. As a patient's exhaled breath is passed through the transducer, the vane rotates. The number of rotations is proportional to the volume of air passed through the transducer, and the frequency of rotation is proportional to the flow rate.
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K Number
K073069Device Name
MODIFICATION TO AVEA VENTILATOR
Manufacturer
VIASYS RESPIRATORY CARE INC
Date Cleared
2008-01-25
(87 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
VIASYS RESPIRATORY CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
Device Description
The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.
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K Number
K062093Device Name
AVEA VENTILATOR
Manufacturer
VIASYS RESPIRATORY CARE INC
Date Cleared
2006-09-20
(58 days)
Product Code
CBK
Regulation Number
868.5895Why did this record match?
Applicant Name (Manufacturer) :
VIASYS RESPIRATORY CARE INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
Device Description
The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.
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