# K971696: Sentinel Recorder, Models 471/472

- Pathway: 510(k) (Traditional)
- Applicant: Del Mar Avionics
- Decided: Dec 30, 1997 after 236 days
- Product code: DXH (Transmitters And Receivers, Electrocardiograph, Telephone)
- Device class: 2
- Regulation: 21 CFR 870.2920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Del Mar Avionics Models 471/472 Sentinel Recorders are ambulatory Electrocardiographic (ECG) recorders intended to acquire multiple brief episodes of ECG information. Acquisition of ECG information is initiated by the patient, normally in response to encountered symptoms. The Model 471 Sentinel Recorder acquires a single channel of ECG. The Model 472 Sentinel Recorder acquires one or two channels of ECG. The Models 471 and 472 Sentinel Recorders are intended to be used as an ECG Cardiac Monitoring Instrument. The Models 471 and 472 Sentinel Recorders are not suitable for monitoring infants weighing less than 22 (10 kg) pounds.

Source page: https://510kreport.com/device/K971696
Methodology: https://510kreport.com/methodology