# K071085: E3-80 Portable Ecg Recorder & Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Micro-Star International Co., Ltd.
- Decided: Oct 3, 2007 after 169 days
- Product code: MWJ (Electrocardiograph, Ambulatory (Without Analysis))
- 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: 2 generations back to K950944 (1996). 3 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K993617: Digitrakplus Holter Recorder, Braemar Corp. (1999) Summary page 1.
- K001025: Lifecard CF Compact Recorder, Reynolds Medical, Ltd. (2000) Summary page 1.

## Most influential descendants
- K101569: V-Trust Model TD-2202 Portable Ecg Recorder (2011), 2 descendants of its own
- K172221: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (2018), 0 descendants of its own
- K131572: Micro Ambulatory Ecg Recorder (2013), 0 descendants of its own

## Indications for use
The E3-80 is a 3-channel portable ECG device designed to record up to 24 hours of ECG signal from the chest surface of adult patients in an ambulatory environment. The device stores ECG data to a removable storage disc for qualified healthcare providers to perform further analysis of recorded ECG.

Source page: https://510kreport.com/device/K071085
Methodology: https://510kreport.com/methodology