AMBULATORY (HOLTER) RECORDING, MODIFICATION

AMBULATORY (HOLTER) RECORDING, MODIFICATION is an FDA 510(k)-cleared medical device (K922027) 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 16, 1993. Regulation: 8.