# K970298: DM-400 Holter Ecg Cassette Recorder

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Monitoring
- Decided: Aug 20, 1997 after 205 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: 1 generation back to K921068 (1992). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K921068: Gikter Ecg Cassette Tape Recorder Model XR 300, Datrix (1992) Summary page 1.
- K930894: Multitrak-Plus, Zymed Medical Instrumentation (1993)

## Indications for use
The DM-400 Holter ECG Cassette Recorder is a device designed for ECG recording of an ambulatory patient.

Source page: https://510kreport.com/device/K970298
Methodology: https://510kreport.com/methodology