HBF-1000 OMRON BODY COMPOSITION ANALYZER

HBF-1000 OMRON BODY COMPOSITION ANALYZER is an FDA 510(k)-cleared medical device (K963575) 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 June 12, 1997. Regulation: 8.