The devices that I found on the FDA website were the products from the Shenzhen Biocare Electronics Co. LTD ECG 1210/ ECG- 1230/ ECG- 3010/ ECG- 6010 which were recently approved in 2/2011. In tracing its predicate devices I found that the original device was first approved in 1982!

Here are the results:

2009: K091513- Smart ECG (SE) Series Electrocardiograph

2001: K014108- MAC 5000 ECG Analysis System

1999: K991735- MAC 5000 Rest ECG Analysis System

1982: K820885- Marquette Option II ECG Analysis Computer for MAC 1 Electrocardiograph

This was a good example of a 510(k) for multiple devices at once because the Shenzhen company submitted this for four of their models at once!

The image above is of the ECG- 1230 model. The image to the right is of the ECG- 1210 model.