# K040753: R-Test Evolution 3

- Pathway: 510(k) (Special)
- Applicant: Novacor
- Decided: Jun 10, 2004 after 78 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
The R-Test Evolution 3 is a miniature ambulatory ECG Event Recorder that is connected to the patient. As the R-Test Evolution (previous model), this version is capable of memorizing the most significant pathological events (symptomatic or silent) as well as the patient's continuous heart rate trend, and is capable of up to eight day ambulatory recording. The registered data could be sent by a modem or by an e-mail application software.

Source page: https://510kreport.com/device/K040753
Methodology: https://510kreport.com/methodology