# K103077: Ecg Pen

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Dynamics Biomedical, Inc.
- Decided: Jul 13, 2011 after 268 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: 3 generations back to K992696 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
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.
- K080933: Handheld Ecg Monitor, Model MD100, Beijing Choice Electronic Technololgy Co., Ltd. (2008) Summary page 1.

## Indications for use
The Vion.ECG Pen (Model no.: 8OOE) is intended for recording EGG data and displaying general information by adult patients who are concerned their heart rhythm and waveform. This Vion.ECG Pen allows the patients to record transient cardiac events voluntarily for providing to the healthcare professionals as references during office visits. In addition, the patient can also record their EGG data and transmit the recorded data to personal computer. The Vion.ECG Pen is not intended for recording and transmission of user's EGG signal simultaneously. Users with implanted pacemakers are not recommended to use this device. This device is not intended to substitute a conventional diagnostic tool.

Source page: https://510kreport.com/device/K103077
Methodology: https://510kreport.com/methodology