MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION

MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION is an FDA 510(k)-cleared medical device (K910291) manufactured by Hewlett-Packard Co.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 21, 1991. Regulation: 8.