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510(k) Data Aggregation
K Number
K973456Device Name
SPIROBANK PORTABLE PC BASED SPIROMETER
Manufacturer
Date Cleared
1998-07-22
(314 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
FUTUREMED AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Spirobank can carry out the FVC, VC & IVC, MVV and respiratory profile tests, measuring more than 20 functional parameters, and also calculate repeatability and test acceptability indices. The functional automatic diagnosis consists of an 11 scale classification, as laid down in the ATS recommendations.
The tests can be performed in adults and pediatrics, in the hospital, clinic and at home.
Results are displayed on the LCD display of the device, and printed on an external printer, transferred to a PC. Memory bank of the device can store several hundred test results which may be transferred to a PC, printed on an external printer, or reviewed on the device at a later date.
Device Description
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K Number
K953948Device Name
SPIROVISION SV-III PC BASED SPIROMETER KIT MICRO
Manufacturer
Date Cleared
1996-06-25
(314 days)
Product Code
Regulation Number
868.1840Why did this record match?
Applicant Name (Manufacturer) :
FUTUREMED AMERICA, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Device Description
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