BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005

BIOSENSOR HOLTER MONITOR SYSTEM SOFTWARE, MODEL 1005 is an FDA 510(k)-cleared medical device (K990956) 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 June 13, 1999. Regulation: 8.