AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION

AMD HOME HEALTH MONITOR SYSTEM AND AMD MONITORING STATION is an FDA 510(k)-cleared medical device (K964697) manufactured by Advance Medical Device, 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 February 10, 1997. Regulation: 8.