NORAV HOLTER SYSTEM, MODEL NH-300 V1.07

NORAV HOLTER SYSTEM, MODEL NH-300 V1.07 is an FDA 510(k)-cleared medical device (K012712) manufactured by Norav Medical , 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 May 7, 2002. Regulation: 8.