OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400

OMRON FAT LOSS MONITOR WITH SCALE, MODEL HBF-400 is an FDA 510(k)-cleared medical device (K043060) manufactured by Omron Healthcare, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 18, 2005. Regulation: 8.