MODIFICATION TO ZYMED HOLTER 2000

MODIFICATION TO ZYMED HOLTER 2000 is an FDA 510(k)-cleared medical device (K992197) 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 July 27, 1999. Regulation: 8.