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510(k) Data Aggregation
K Number
K063044Device Name
CARDIOBELT ELECTRODE BELT
Manufacturer
MONEBO TECHNOLOGIES, INC.
Date Cleared
2007-03-23
(170 days)
Product Code
DRX
Regulation Number
870.2360Why did this record match?
Applicant Name (Manufacturer) :
MONEBO TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CardioBelt™ is a single patient reusable electrode system intended for use in general electrocardiographic procedures where ECG monitoring is deemed necessary and is ordered by a physician. The CardioBelt™ is compatible for use with Bluetooth equipped ECG instruments capable of receiving Bluetooth™ Serial Port Protocol.
Device Description
The Monebo CardioBelt™ is a reusable electrode system consisting of an electrode assembly, an elastic chest belt, and an electronics package containing a Bluetooth transceiver. The CardioBelt™ electrodes are positioned against the patient's skin with light pressure, using the elastic chest belt. The CardioBelt™ is designed to be used without electrolytic gels and without adhesives on unprepared skin; that is without the requirements for shaving, abrading, or other skin preparation. The CardioBelt transmits ECG information to a compatible Bluetooth enabled device. The CardioBelt contains a class II Bluetooth radio with a range of approximately 30 feet (spherical range). The CardioBelt™ is powered by a rechargeable lithium ion battery. The electronics package must be physically separated from the electrode belt to charge the battery.
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K Number
K062282Device Name
MONEBO AUTOMATED ECG ANALYSIS AND INTERPRETATION SOFTWARE LIBRARY, VERSION 3.0
Manufacturer
MONEBO TECHNOLOGIES, INC.
Date Cleared
2007-03-22
(227 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MONEBO TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Automatic Analysis and Interpretation Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory ECG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Hotter, Event Monitor, 12 lead ambulatory or resting ECG devices, or other similar devices when assessment of the rhythm is necessary. The Automatic Analysis and Interpretation Software Library can also be electronically interfaced, and perform analysis with data transferred from other computer based ECG systems, such as an ECG management system. The Automatic Analysis and Interpretation Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, QRS feature extraction, interval measurement, heart rate measurement, and rhythm analysis for up to sixteen(16) leads of captured data. The library is not for use in life supporting or sustaining systems or ECG monitoring and Alarm devices. The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.
Device Description
The Monebo Automated ECG Analysis and Interpretation Software Library is an "object library". An object library is a collection of callable functions that have been complied (or assembled) into machine code or IDL code of the computer on which they execute. The Monebo Automated ECG Analysis and Interpretation Software Library consists of a basic application for viewing, analyzing and annotating ECG data, and a callable object library built on the Microsoft .Net framework. An application software program can be written to invoke some or all of the functions in an object library. The Monebo Automated ECG Analysis and Interpretation Software Library provides ECG signal processing, QRS detection and measurement of duration, QRS feature extraction, classification of Normal and Ventricular Ectopic beats, heart rate measurement, measurement of PR and QT intervals, and rhythm interpretation for up to 16 leads of captured ECG data. The library can be accessed through an Application Program Interface (API) as a callable function. This allows the library to be used as an accessory to an ECG management application or as a stand-alone product. Monebo will compile the Monebo Automated ECG Analysis and Interpretation Software Library specified by an ECG device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into application software for their ECG analysis.
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K Number
K043380Device Name
MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1
Manufacturer
MONEBO TECHNOLOGIES, INC.
Date Cleared
2005-04-26
(139 days)
Product Code
DPS
Regulation Number
870.2340Why did this record match?
Applicant Name (Manufacturer) :
MONEBO TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Automatic Arrhythmia Detection Software Library is intended for use by qualified medical professionals for assessing historic ambulatory ECG data. The product allows downloading and analyzing data recorded in compatible format by Holter or Event monitoring devices. The Automatic Arrhythmia Detection Software Library provides ECG signal processing and analysis on a beat by beat basis, QRS and Ventricular Ectopic Beat detection, and QRS feature extraction.
The product can be integrated into computerized ECG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.
Device Description
The Monebo Automatic Arrhythmia Detection Software Library is an "object library". An object library is a collection of callable functions that have been complied (or assembled) into machine code or IDL code of the computer on which they execute. The Automatic Arrhythmia Detection Software Library consists of a basic application for viewing, analyzing and annotating ECG data and callable object library built on the Microsoft .Net framework. An application software program can be written to invoke some or all of the functions in an object library.
The Monebo Automatic Arrhythmia Detection Software Library provides ECG signal processing, QRS detection, QRS feature extraction, and ventricular ectopic beat detection for up to 12 leads of captured ECG data.
Monebo will compile the Automatic Arrhythmia Detection Software Library specified by an ECG analysis device manufacturer. An object library will be created and delivered to the device manufacturer, who can then integrate it into application software for their ECG analysis. The device manufacturer will be required to submit a 510k with the specific requirements for that device.
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