Quantitative Electrocardiographic Detector (QED 2000)

Quantitative Electrocardiographic Detector (QED 2000) is an FDA 510(k)-cleared medical device (K152135) manufactured by Acme Portable Machines, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 8, 2016. Regulation: 8.