MINI-HOLTER, MODEL 2000

MINI-HOLTER, MODEL 2000 is an FDA 510(k)-cleared medical device (K862526) manufactured by Holter Recorders. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 24, 1986. Regulation: 8.