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510(k) Data Aggregation
K Number
K981720Device Name
IQ SYSTEM
Manufacturer
RENAISSANCE TECHNOLOGY, INC.
Date Cleared
1999-02-08
(279 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
RENAISSANCE TECHNOLOGY, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As with predicate devices indicated in this resubmittal (cardiac output monitors employing impedance plethysmography {DXG and DSB}), the IQ™ System is intended for use by qualified health care practitioners, under direction of a physician, for the non-invasive monitoring and management of cardiac function in a variety of medically accepted clinical applications. The IQ™ System (as well as predicate devices) is especially useful in cases where the invasive monitoring of cardiac output (e.g.: thermodilution) may compromise a given patient, is impractical, or otherwise contraindicated.
Device Description
"IQ™ System" Cardiac Output Monitor
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