LOG-A-RYTHM MODEL 100 AND MODEL 1001

LOG-A-RYTHM MODEL 100 AND MODEL 1001 is an FDA 510(k)-cleared medical device (K952790) manufactured by Nian-Crae, 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 October 16, 1996. Regulation: 8.