# K993618: DXP1000 Holter Recorder

- Pathway: 510(k) (Special)
- Applicant: Braemar Corp.
- Decided: Nov 24, 1999 after 29 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: 1 generation back to K950944 (1996). 1 ancestor in all.
43 later devices descend from it; 6 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950944: Ambulatory (Holter) Recording System, Biosensor Corp. (1996) Summary page 1.

## Most influential descendants
- K113176: Mysense Heart (2011), 16 descendants of its own
- K131190: Mypatch (2013), 15 descendants of its own
- K160704: myPatch-s (2016), 14 descendants of its own
- K070818: MEDILOGAR4, MEDILOGAR12 (2007), 14 descendants of its own
- K083820: Vasomedical Biox CB-1305-C, 3 Channel Ecg Holter Monitor, Model CB-1305-C (2009), 12 descendants of its own

## Indications for use
The electrocardiogram (ECG) is a graphic description of the electrical activity of the heart. This activity is recorded from 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 powerful basis for evaluation of these biophysical signals. Twenty-four or forty-eight hour ECG recordings can be of great value in patient assessment. Ambulatory (Holter) ECG intended use: The DigiTrakPlus Holter recorder is intended for patients requiring ambulatory (Holter) monitoring from 1 to 48 hours. Such monitoring is most frequently used for the indications below. 1. Evaluation of symptoms suggesting arrhythmia or myocardial ischemia. 2. Evaluation of ECG documenting therapeutic interventions in individual patients or groups of patients. 3. Evaluation of patients for ST segment changes. 4. Evaluation of a patient’s response after resuming occupational or recreational activities (e.g., after M.1. or cardiac surgery.) 5. Clinical and epidemiological research studies. 6. Evaluation of patients with pacemakers 7. Reporting of time and frequency domain heart rate variability 8. Reporting of QT Interval

Source page: https://510kreport.com/device/K993618
Methodology: https://510kreport.com/methodology