AMBULATORY (HOLTER) RECORDING SYSTEM

AMBULATORY (HOLTER) RECORDING SYSTEM is an FDA 510(k)-cleared medical device (K950723) manufactured by Biosensor Corp.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 8, 1996. Regulation: 8.