# K131897: CV3000 Holter Analysis System

- Pathway: 510(k) (Traditional)
- Applicant: Vales & Hills Biomedical Tech., Ltd.
- Decided: Nov 26, 2013 after 154 days
- Product code: MLO (Electrocardiograph, Ambulatory, With Analysis Algorithm)
- Device class: 2
- Regulation: 21 CFR 870.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K911097 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101273: Dynamic Ecg System Model TLC5000, Contec Medical System Co., Ltd. (2011) Summary page 2.

## Indications for use
The proposed device is intended to continuously acquire ambulatory ECG data for up to twelve leads or five leads. It can record the ECG data for twenty four hours. The ECG data obtained will be stored in the recorder first and then download to PC for analysis, reviewing and printing by a trained physician in health facilities.

Source page: https://510kreport.com/device/K131897
Methodology: https://510kreport.com/methodology