EKG Predicate Devices

To better understand how electrocardiographs are brought to market, we researched the Premarket Notification or 510(k) for various devices. The 510(k) notification indicates that a device is "substantially equivalent" to a prior technology. Companies seeking approval must prove the similarity between their new creation and a past creation. This is a necessary process regulated by the U.S. Food and Drug Administration (FDA). By going through the summary reports of the 510(k)'s, we are able to trace a technological ancestry from a modern device to a more foundational device.

2010: Electrocardiograph, Edan Instruments Inc. [510(k) Summary]
-2002: MAC 5000 ECG Analysis System, GE Medical Systems IT [510(k) Summary]
--1999: MAC Series Electrocardiographs, GE Medical Systems IT [510(k) Summary]
---1982: Marquette Option II ECG Analysis, Marquette Electronics Inc. [510(k) Summary]

For a device with over a century of history, we are not surprised to find a long predicate device ancestry for the electrocardiograph.