# K062282: Monebo Automated Ecg Analysis and Interpretation Software Library, Version 3.0

- Pathway: 510(k) (Traditional)
- Applicant: Monebo Technologies, Inc.
- Decided: Mar 22, 2007 after 227 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003621 (2000). 3 ancestors in all.
70 later devices descend from it; 9 cite it directly.
0 of 74 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043380: Monebo Automatic Arrhythmia Detection Software Library, Version 1, Monebo Technologies, Inc. (2005) Summary page 2.
- K003621: ST/AR ST and Arrhythmia Software, Model Release D.0, Agilent Technologies, Inc. (2000) Summary page 2.
- K013717: Brentwood Real Time ST and Arrhythmia Analysis Software Library, Brentwood Medical Technology Corp. (2002) Summary page 2.

## Most influential descendants
- K091075: Zeus (Zio Ecg Utilization Service) System (2009), 32 descendants of its own
- K142681: ZEUS (ZIO ECG Utilization Service) System (2014), 31 descendants of its own
- K143513: ZIO SR ECG Monitoring Service (2015), 30 descendants of its own
- K170568: CardioLogs ECG Analysis Platform (2017), 26 descendants of its own
- K163512: Zio AT ECG Monitoring System (2017), 18 descendants of its own

## Indications for use
The Automatic Analysis and Interpretation Software Library is intended for use by qualified medical professionals for the assessment of arrhythmias using historic ambulatory EGG data. The product supports downloading and analyzing data recorded in compatible formats from any device used for the arrhythmia diagnostics such as Holter, Event Monitor, 12 lead ambulatory or resting EGG 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 EGG systems, such as an EGG management system. The Automatic Analysis and Interpretation Software Library provides EGG 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 EGG monitoring and Alarm devices The product can be integrated into computerized EGG monitoring devices. In this case the medical device manufacturer will identify the indication for use depending on the application of their device.

Source page: https://510kreport.com/device/K062282
Methodology: https://510kreport.com/methodology