AMBULATORY X-12 TELEMETRY MODULE

AMBULATORY X-12 TELEMETRY MODULE is an FDA 510(k)-cleared medical device (K974149) manufactured by Mortara Instrument, 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 January 7, 1998. Regulation: 8.