PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400

PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 is an FDA 510(k)-cleared medical device (K945985) manufactured by Burdick, Inc.. 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 2, 1995. Regulation: 8.