# K954163: Retrospective II-Elite Ecg Memory Loop Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Cardiac Evaluation Center, Inc.
- Decided: Jul 11, 1996 after 310 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K831406 (1983). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K831406: Restrospective Ecg Memory Module, Cardiac Evaluation Center, Inc. (1983) Summary page 1.

## Indications for use
The sole intended use for the device or its predicate is for the long term monitoring of ECG in occasionally symptomatic patients. The purpose of both devices is to record occasional short-lived arrhythmia. Their usage is usually confined to otherwise healthy individuals on an out-patient basis. These recorders are not meant for use in life support or ICU situations. Their normal function is to record all ECG data and save a particular episode only when activated by the patient. The stored episode contains data before and after the activation so that the actual arrhythmia will be captured. The data is then saved for transmission to a qualified technician for interpretation. The recorders take no action and advises none to the patient other than to call the receiving station. They are totally passive devices and offers no diagnosis or perform any signal analysis.

Source page: https://510kreport.com/device/K954163
Methodology: https://510kreport.com/methodology