# K110328: Acg-8511 Portable Ecg Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Andon Health Co, Ltd.
- Decided: Jul 15, 2011 after 162 days
- Product code: DPS (Electrocardiograph)
- Device class: 2
- Regulation: 21 CFR 870.2340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K992696 (1999). 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)
- K060766: Portable,  Electrocardiograph (Ecg) Monitor, Model HCG-801, Omron Healthcare, Inc. (2006) Summary page 1.

## Indications for use
The ACG-851 1 portable ECG Monitor is intended for recording and displaying ECG data by adult patients who are concerned about their heart rhythm. This ACG-851 1 portable EGG Monitor allows the consumer to record their ECG data into the device memory for display by healthcare professionals during office visits. Specifically, ACG-851 1 portable EGG Monitor is intended for adult patients who are concerned about their heart rhythm or have experienced the following symptoms that are suggestive of abnormal heart rhythm: -Skipped beats -Pounding heart (palpitations) -History of arrhythmia

Source page: https://510kreport.com/device/K110328
Methodology: https://510kreport.com/methodology