NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS

NOVACOR'S R-TEST 60 & R-TEST 160 ECG RECORDERS is an FDA 510(k)-cleared medical device (K844391) manufactured by Ams Medical, 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 January 6, 1985. Regulation: 8.