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510(k) Data Aggregation
K Number
K031229Device Name
TELZUIT CARDIAC MONITORING SYSTEM
Manufacturer
Date Cleared
2003-07-09
(82 days)
Product Code
Regulation Number
870.2920Why did this record match?
Applicant Name (Manufacturer) :
TELZUIT TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The TelZuit Cardiac Monitoring System consists of a 4-channel ECG (electrocardiograph) monitor (TelZuit Electrode Array Patch) and the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder stores and transmits data received from the TelZuit Electrode Array Patch via telephone to a remotely located ECG analysis station for evaluation by a medical professional.
Device Description
The TelZuit Cardiac Monitoring System is a transtelephonic ambulatory ECG recorder consisting of the TelZuit Electrode Array Patch and TelZuit Cardiac Monitoring Recorder. These components, when used together, allow a patient to collect and transmit their ECG data to an analysis station for evaluation by a medical professional.
The TelZuit Electrode Array Patch is a multi-layer patch containing four embedded ECG electrodes and leads and a transmitter mounted on a Mylar substrate that is affixed to the patient's chest for monitoring ECG activity. Two models, Models A and B, are available that differ in lead placement and configuration. The electrode configuration in the TelZuit Electrode Array Patch Model A corresponds to positions of Lead I, Lead II, Lead III, and V2 for use with 12 Lead Algorithms. The electrodes in the TelZuit Electrode Array Patch Model B are positioned orthogonally so that the leads correspond to positions of EASI & G for use with Modified Frank Algorithms.
Each TelZuit Electrode Array Patch model is supplied in different sizes with lengths of 8.0, 8.5, 9.0, and 9.5 inches (203, 216, 229, 241 mm). The electrodes incorporated in all versions of the TelZuit Electrode Array Patch are identical to electrodes cleared for marketing by Bristol Medical Electronics, Inc., (K841944) and comply with ANSI/AAMI EC 12, "Disposable ECG Electrodes."
The TelZuit Cardiac Monitoring Recorder captures and stores digitized ECG data transmitted from the TelZuit Electrode Array Patch, and transmits this information to a remotely located receiving and analysis station via a modified Samsung Portable Dualband Tri-Mode personal digital assistant (PDA) with cellular telephone The device has a touchscreen LCD display. Recording and capabilities. transmission of ECG data occurs continuously while the TelZuit Electrode Array Patch and TelZuit Cardiac Monitoring Recorder are active. The patient may also record a cardiac event via the LCD display screen on the TelZuit Cardiac Monitoring Recorder. The TelZuit Cardiac Monitoring Recorder also continuously monitors the operational status of the TelZuit Cardiac Monitoring System and informs the user if an error is detected.
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