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510(k) Data Aggregation
K Number
K140102Device Name
PHYSIOFLOW Q-LINK
Manufacturer
VASOCOM, INC.
Date Cleared
2014-02-12
(28 days)
Product Code
DSB, DBS
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
VASOCOM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use in adults only.
The PhysioFlow Q-Link noninvasively measures cardiac output and other related cardiac parameters. These parameters include:
CI Cardiac Index
CO Cardiac Output
CTI Contractility Index
dZ / dt max Maximum value dZ / dt
EDV End Diastolic Volume
EF Ejection Fraction
HR Heart Rate
LCWI Left Cardiac Work Index
PEP Pre-Ejection Period
SV Stroke Volume
SVR Systemic Vascular Resistance
SVRI Systemic Vascular Resistance Index
TFI Thoracic Fluid Index
VET Ventricular Ejection Time
ZO Base Impedance
The PhysioFlow Q-Link is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Device Description
The PhysioFlow Q-Link is a noninvasive, hemodynamic monitor that utilizes thoracic electrical bioimpedance technology to measure cardiac output and related cardiac parameters. It consists of a small, portable, lightweight electronic unit that attaches to the patient via a six lead, patient cable using commercially available silver/silver chloride skin electrodes. Monitor data is transmitted to a host computer running the PhysioFlow PF107 software. Communication to the host computer is via USB wired technology. The PhysioFlow PF107 software performs multiple tasks including signal processing and analysis, measured parameter computation, user interface display and control, measurement process control, event marker management, and output display/report generation. Available accessories include the patient and USB cables.
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K Number
K103283Device Name
PHYSIOFLOW ENDURO
Manufacturer
VASOCOM, INC.
Date Cleared
2010-12-03
(28 days)
Product Code
DSB, DBS
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
VASOCOM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for use in adults only. The PhysioFlow Enduro PF07 noninvasively measures cardiac output and other related cardiac parameters. These parameters include: CI (Cardiac Index), CO (Cardiac Output), CTI (Contractility Index), dZ / dt max (Maximum value dZ / dt), EDV (End Diastolic Volume), EF (Ejection Fraction), HR (Heart Rate), LCWI (Left Cardiac Work Index), PEP (Pre-Ejection Period), SV (Stroke Volume), SVR (Systemic Vascular Resistance), SVRI (Systemic Vascular Resistance Index), TFI (Thoracic Fluid Index), VET (Ventricular Ejection Time), and ZO (Base Impedance). The Enduro System Model PF-07 is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Device Description
The PhysioFlow Enduro Model PF07 is a noninvasive, hemodynamic monitor that utilizes thoracic electrical bioimpedance technology to measure cardiac output and related cardiac parameters. It consists of a small, portable, lightweight (less than 250 gm with batteries) electronic unit that attaches to the patient via a six lead, patient cable using commercially available silver/silver chloride skin electrodes. The electronic unit incorporates recorder capabilities, enabling it to capture and store up to 24 hours of monitor data for later transmission to a host computer running the PhysioFlow PF107 software. Communication options include Bluetooth wireless and USB wired technology. The PhysioFlow PF107 software performs multiple tasks including signal processing and analysis, measured parameter computation, user interface display and control, measurement process control, event marker management, and output display/report generation. Available accessories include the patient cable, a Bluetooth antenna. USB cable, and electronic unit carrying case.
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K Number
K060387Device Name
PHYSIOFLOW SYSTEM
Manufacturer
VASOCOM, INC.
Date Cleared
2008-04-10
(786 days)
Product Code
DSB
Regulation Number
870.2770Why did this record match?
Applicant Name (Manufacturer) :
VASOCOM, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PhysioFlow System noninvasively measures cardiac output and other related cardiac parameters on adults. These parameters include: CI, Cardiac Index; CO, Cardiac Output; CTI, Contractility Index; EDV, End Diastolic Volume; EF, Ejection Fraction; HR, Heart Rate; LCWI, Left Cardiac Work Index; PEP, Pre Ejection Period; SV, Stroke Volume; SVR, Systemic Vascular Resistance; SVRI, Systemic Vascular Resistance Index; TFI, Thoracic Fluid Index; LVET, Left Ventricular Ejection Time. The PhysioFlow System is intended for use under the direct supervision of a licensed healthcare practitioner or personnel trained in its proper use within a hospital or facility providing healthcare.
Device Description
The PhysioFlow System is a noninvasive hemodynamic monitor that uses thoracic electrical bioimpedance technology to measure cardiac output and related parameters. It has three main components: 1. An electronic device that generates a low magnitude, high frequency electrical current, sends it through the body of the patient via a patient cable and pre-gelled electrodes, and receives it after it has crossed the patient thorax. The impedance modulation (ΔΖ) is extracted from the received signal, providing a pulsatile waveform used by the software to compute stroke volume. The device also records one lead of a passive electrical signal that is similar to the ECG, in order to provide a time basis and trigger for the analysis of the impedance waveform, and to provide a measurement of heart rate. This ECG signal is not used for electrocardiography analysis. The device filters and digitizes both the impedance and the ECG signals, and transmits them to a computer via a serial communications link. The device has an analog output option, which makes the following signals available: ΔZ, ECG, Cardiac Output trend, and Stroke Volume trend. 2. A computer that runs a MS-Windows operating system, and performs the following tasks: Reception of digitized signal samples from the device via a serial port; Platform to operate the PhysioFlow software; Physical user interface (keyboard, mouse, display); Patient data storage capacity (on hard disk); (Optional) Reception of blood pressure values from an external blood pressure monitor device via a serial port (This device does not measure blood pressure); Management of a printer using the appropriate driver. 3. The PhysioFlow software, which performs following tasks: Signal processing and analysis; Computation of measured parameters; User interface and control of the measurement process (entering patient data, calibration procedure, monitoring phase, post processing of measurement results); Transmitting cardiac output and stroke volume values back to the device via a serial data link for analog output purposes; Management of event markers; Setup of measurement and screen configuration (averaging ratio, scales, screen appearance, printout options); Display of signal, trends, and graphics; Management of imported data (blood pressure values from external monitor); Management of patient data; Export of measurement data in text format (for import into programs such as Excel); Generating hard copy output.
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