# K963375: Cardiacmonitor

- Pathway: 510(k) (Traditional)
- Applicant: Vision Electronics
- Decided: Feb 28, 1997 after 185 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. The FDA summary names its predicate without a number.
- (no number) Heartland: named in the summary without a submission number

## Indications for use
The CardiacMonitor is a non-invasive, external ambulatory electrocardiographic (ECG) looping memory monitor. The device is activated by the patient who experiences transient symptoms and is intended for human use, in the home or workplace.

Source page: https://510kreport.com/device/K963375
Methodology: https://510kreport.com/methodology