# K843503: Aegis Ambulatory Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Aegis Medical Systems, Inc.
- Decided: Oct 26, 1984 after 50 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 1 cites it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K982803: Heartlink, Model II (1998), 26 descendants of its own
- K071995: CG-6108 Continuous Ecg Monitor and Arrhythmia Detector (2007), 25 descendants of its own
- K081257: CG-6108 Act-3L Continuous Ecg Monitor & Arrhythmia Detector (2008), 18 descendants of its own
- K093288: Cardionet Ambulatory Ecg Monitor with Arrhythmia Detection (2010), 7 descendants of its own
- K090037: Medicalgorithmics Real-Time Ecg Monitor and Arrhythmia Detector, Model Pocketecg (2009), 7 descendants of its own

Source page: https://510kreport.com/device/K843503
Methodology: https://510kreport.com/methodology