# K060911: CG-6108 Arrhythmia Ecg Event Recorder

- Pathway: 510(k) (Special)
- Applicant: Card Guard Scientific Survival, Ltd.
- Decided: Aug 22, 2006 after 141 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
Longest line of descent: 3 generations back to K963725 (1997). 7 ancestors in all.
44 later devices descend from it; 2 cite it directly.
0 of 52 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K963811: Card Guard Model CG-6106 Personal Electrocardiogram (Ecg) Transmitter Device, Card Guard Scientific Survival, Ltd. (1996) Summary page 2.
- K003220: Personal Ecg Transmitter, Model CG-6550, Card Guard Scientific Survival, Ltd. (2000) Summary page 2.
- K042254: PMP4 Selfcheck Ecg, Card Guard Scientific Survival, Ltd. (2005) Summary page 2.

## Most influential descendants
- 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
- K083535: Heartrak Smart Ecat (2008), 17 descendants of its own
- K131699: Emotion Ecg Mobile (2013), 16 descendants of its own
- K141813: Rhythmstar System (2014), 8 descendants of its own

## Indications for use
Intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia

Source page: https://510kreport.com/device/K060911
Methodology: https://510kreport.com/methodology