HOMEVUE WOUND MONITORING SYSTEM

HOMEVUE WOUND MONITORING SYSTEM is an FDA 510(k)-cleared medical device (K945807) manufactured by Homevue Health Systems, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 6, 1995. Regulation: 8.