# K080933: Handheld Ecg Monitor, Model MD100

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Choice Electronic Technololgy Co., Ltd.
- Decided: Sep 26, 2008 after 177 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.
1 later device descends from it; 1 cites it directly.
0 of 4 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.

## Most influential descendants
- K103077: Ecg Pen (2011), 0 descendants of its own

## Indications for use
The Handheld ECG Monitor MD100 is intended for use in non-invasive recording and displaying ECG waveform by adult patients. In addition, it also can provide to the treating physician with relevant data on the cardiac rhythm in hospital patients. It is immediately available at any time to manually record transient cardiac events, suitable for patient and professional use, helpful in determining the cardiac rhythm at the time of symptoms. This ECG monitor allows the patient to record their ECG data into the device memory for display by healthcare professional during office visits. The product is not a conventional diagnostic tool.

Source page: https://510kreport.com/device/K080933
Methodology: https://510kreport.com/methodology