WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0

WVSM (WIRELESS VITAL SIGNS MONITOR), MODEL 5.0 is an FDA 510(k)-cleared medical device (K101674) manufactured by Athena Gtx. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 20, 2010. Regulation: 8.