AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS

AUTOMATIC DIGITAL BLOOD PRESSURE METERS, MODELS is an FDA 510(k)-cleared medical device (K912588) manufactured by Sein Electronics Co., Ltd.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 18, 1991. Regulation: 8.