ZYMED HOLTER SCANNER MODEL 2010

ZYMED HOLTER SCANNER MODEL 2010 is an FDA 510(k)-cleared medical device (K955015) manufactured by Zymed Medical Instrumentation. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 1996. Regulation: 8.