# K030856: ER800 Series Ecg Event Recorder

- Pathway: 510(k) (Special)
- Applicant: Braemar Corp.
- Decided: Mar 28, 2003 after 10 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 K923930 (1992). 4 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981394: Braemar ER700 Series Ambulatory Ecg Event Monitor Models ER710,ER720, Braemar Corp. (1998) Summary page 1.
- K950944: Ambulatory (Holter) Recording System, Biosensor Corp. (1996) Summary page 1.
- K993618: DXP1000 Holter Recorder, Braemar Corp. (1999) Summary page 1.

## Most influential descendants
- K061293: Telaheart Digital Recorder (2006), 5 descendants of its own
- K142424: DR300 Holter Monitor (2014), 3 descendants of its own
- K151787: Holter System (2016), 2 descendants of its own
- K254119: Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303) (2026), 0 descendants of its own
- K251591: Holter ECG and ABP system (HolterABP) (2026), 0 descendants of its own

## Indications for use
To record infrequent and elusive ECG heart arrhythmia data. Once data is recorded, patients transmit the recorded ECG data over the telephone or directly to a host PC for review. The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded form the body surface by a group of electrodes positioned at predefined places to reflect the activity from different perspectives. Depending on how these electrodes are placed, the ECG waveforms are considered as separate linearly dependent signals. Presently the ECG is the most prominent and widely used non-invasive cardiac diagnostic technique. There exists a significant accumulation of correlated clinical data, which provides a powerhl basis for evaluation of these biophysical signals.

Source page: https://510kreport.com/device/K030856
Methodology: https://510kreport.com/methodology