INFRASONDE D4000 ELECTRONIC B-P MONITOR

INFRASONDE D4000 ELECTRONIC B-P MONITOR is an FDA 510(k)-cleared medical device (K800401) manufactured by Sphygmetrics, 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 March 11, 1980. Regulation: 8.