FDA Market Approved 510(k) Devices

A 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent (SE), to a legally marketed device that is not subject to premarket approval (PMA).

Devcoms Instant-Read ECG Caliper carries a 510(k) marketing approval from the FDA. This handy tool provides an accurate direct measurement of Heart Rate, Wave Amplitude, P-R, QRS and Q-T Intervals, without the need to use an ECG ruler for conversion. This device is one that physicians and health care providers frequently request.