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510(k) Data Aggregation
K Number
K052176Device Name
FLOWHANDY ZAN100 USB
Manufacturer
ZAN MESSGERATE GMBH
Date Cleared
2006-01-12
(155 days)
Product Code
BZG
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
ZAN MESSGERATE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flowhandy ZAN100 USB is an open, personal-computer-based spirometry system with optional shutter for measuring and analyzing breath flow, volume, and pressure in adult and pediatric subjects for use by pulmonologists, allergists, general practitioners, and occupationalmedicine practitioners in lung-function diagnosis.
Device Description
The Flowhandy ZAN100 USB is a pneumotachometer spirometry system. The system comprises a Windows personal computer (sold separately) for data collection, analysis, storage, and display; proprietary Betterflow ZAN100 USB software program for the PC; and a Flowlandy, hand-held pneumotach with reusable variable-orifice core, differential pneumatic pressure sensor, and USB interface. An optional computer-controlled shutter may be added to the air passageway to interrupt flow to allow pressure measurements using the on-board pressure sensor.
The ZAN100 measures the pressure drop across the known orifice to indicate the rate of breath flow both in and out of the air passageway. Knowing the flow rate of air from a subject allows the calculation of the most recognized spirometric values for the subject. Closing off the passageway with the optional shutter enables the pressure sensor to take important pressure measurements for the subject's breathing as well.
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K Number
K052328Device Name
ZAN LUNG-FUNCTION LAB
Manufacturer
ZAN MESSGERATE GMBH
Date Cleared
2005-12-22
(119 days)
Product Code
BZC
Regulation Number
868.1880Why did this record match?
Applicant Name (Manufacturer) :
ZAN MESSGERATE GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ZAN Lung-Function Lab is used to measure or monitor pulmonary function in adult and pediatric subjects during exercise (including diagnosis, training, and stress testing) or while at rest (including Spirometry, airway strength and output, diffusion capacity, body plethysmography, nutritional assessment, and indirect cardiac output) for diagnosis, training, assessment, and other related activities.
Device Description
The ZAN Lung-Function Lab (LFL) is a full-featured, PC-based system for professional evaluation of pulmonary function, cardiopulmonary exercise capacity, and metabolism. A personal computer (PC) is the central component of the system, collecting data from pulmonary instruments, calculating lung-function test, stress, and training parameters, entering demographic and other subject information, and displaying/reporting the results. The system comprises Four pulmonary instruments (flow sensor with airway pressure capability, diffusion-gas analyzer, ventilation-gas analyzer, and body plethysmograph), a PC running a proprietary ZAN test program, test gases of known compositions, leads, tubes, and valves connecting the instruments and computer, and an optional cart for normalizing expansion. In addition, optional physiologic sensing equipment (including exercise electrocardiographs, pulse oximeters, etc.) may supply data to the LFL to provide expanded testing capability.
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