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510(k) Data Aggregation
K Number
K014299Device Name
SORBA STEORRA NON-INVASIVE IMPEDANCE CARDIOGRAPH
Manufacturer
Date Cleared
2002-01-30
(30 days)
Product Code
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
SORBA MEDICAL SYSTEMS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Steorra™ by SORBA is a noninvasive hemodynamic monitor based on the technology of impedance cardiography. The Steorra™ measures the following cardiac parameters: heart rate (HR); stroke volume (SV) and Cardiac Output (CO) The Steorra™ can be configured with optional noninvasive blood pressure (NIBP) technology. When blood pressure data are available (via the NIBP, analog input from an invasive monitor, or manual input), then systolic, diastolic and mean blood pressures are displayed with rate pressure product (RPP). If central venous pressure (CVP) is input as an analog signal from an invasive monitor, then CVP is displayed and systemic vascular resistance (SVR) is calculated and displayed.
Device Description
SORBA Steorra Non-Invasive Impedance Cardiograph
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