# K140847: Cardiospy Ecg Holter Systems

- Pathway: 510(k) (Traditional)
- Applicant: Labtech Kft.
- Decided: Dec 5, 2014 after 246 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: 5 generations back to K930806 (1994). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042108: Vista Plus, Novacor (2005) Summary page 5.
- K032466: Spiderview, Ela Medical, Inc. (2003) Summary page 5.
- K022540: Cardio ID+(RZ153+), Rozinn Electronics, Inc. (2002) Summary page 5.
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 5.

## Most influential descendants
- K182030: Faros Mobile (2018), 0 descendants of its own

## Indications for use
The Cardiospy ECG Holter System is intended for use in a clinical, by qualified professionals, for patients requiring ambulatory (Holter) monitoring 24, 48, 72, 168 h hours. Such monitoring is most frequently used for purpose of prospective and retrospective cardiac data and arrhythmia analysis. The System, among others, provides the detection and reporting features appropriate to the indications below for children and adults of all ages (up to 2 years): * Evaluation of patients with symptoms related to rhythm disturbances or symptoms suggesting arrhythmia. * Evaluation of patients for ST segment changes * Evaluation of patients with pacemakers Reporting of time domain heart rate variability « Evaluation of a patient's response after resuming occupational or recreational activities (e.g., after MI. or cardiac surgery.) « Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients * Clinical and epidemiological research studies

Source page: https://510kreport.com/device/K140847
Methodology: https://510kreport.com/methodology