NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100

NEXSYSTEM AMBULATORY PATIENT MONITOR MODEL NEX 100 is an FDA 510(k)-cleared medical device (K993643) manufactured by Nexan Telemed , Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 27, 1999. Regulation: 8.