# K062007: DMS 300-7

- Pathway: 510(k) (Special)
- Applicant: Diagnostic Monitoring Software
- Decided: Aug 16, 2006 after 30 days
- Product code: DSH (Recorder, Magnetic Tape, Medical)
- 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 K921068 (1992). 4 ancestors in all.
2 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)
- K923664: Scole 300 Ecg Recorder, Scole Engineering Co. (1994) Summary page 1.
- K982975: Digital Ecg Holter Recorder, Model DR512, Datrix (1998) Summary page 1.

## Most influential descendants
- K062959: DMS 300-2, 300-3 and 300-4 (2006), 1 descendant of its own
- K133014: DMS 300-2W Holter Ecg Recorder (2014), 0 descendants of its own

## Indications for use
The DMS 300-7 Holter ECG recorder is intended to acquire, record, and store up to 24-hours of three (3) channel ECG data for patients undergoing continuous ambulatory electrocardiography. The DMS 300-7 performs no cardiac analysis by itself and is intended to be used with the DMS Premier Holter system. In turn, the cardiac data and analysis provided by the Premier Holter system will be reviewed, confirmed, and used by trained medical personnel in the diagnosis of patients with various rhythm patterns. The DMS 300-7 is indicated for use in a clinical setting, by qualified medical professionals only, for recording ECG data of patients requiring ambulatory (Holter) monitoring of up to 24-hours. Holter ECG is appropriate for the indications below: .Evaluation of adult patients with symptons suggesting arrhythmia .Evaluation of adult patients with pacemakers .Evaluation of patients with suspected abnormal heart rate changes .Evaluation of patients with suspected abnormal QRS interval changes .Evauation of patients with drug therapy treatment

Source page: https://510kreport.com/device/K062007
Methodology: https://510kreport.com/methodology