# K062959: DMS 300-2, 300-3 and 300-4

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Monitoring Software
- Decided: Oct 16, 2006 after 17 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: 3 generations back to K921068 (1992). 5 ancestors in all.
1 later device descends 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)
- K062007: DMS 300-7, Diagnostic Monitoring Software (2006) Summary page 1.
- K923664: Scole 300 Ecg Recorder, Scole Engineering Co. (1994) Summary page 2.

## Most influential descendants
- K133014: DMS 300-2W Holter Ecg Recorder (2014), 0 descendants of its own

## Indications for use
The "Indications for Use" of the modified DMS 300-2, 300-3 and 300-4 recorders are indicated for use in a clinical setting, by qualified medical professionals only, for recording multi-lead ECG data of patients during a minimum ambulatory time period of 24-hours. It is not a life supporting system, and is not connected to an AC power source. The "Intended Uses" of the modified 300-2, 300-3, and 300-4 Holter ECG Recorders are exactly the same as the predicate devices (DMS 300-7 and 300 ECG Recorder). Ambulatory multi-day electrocardiography is used for the below indications: * Evaluation of patients with symptoms suggesting arrhythmias. * Evaluation of patients with pacemakers. * Evaluation of patient heart rate changes and QRS interval changes. * Evaluation of patient response to drug therapy treatment.

Source page: https://510kreport.com/device/K062959
Methodology: https://510kreport.com/methodology