Endophys Blood Pressure Monitor model BPM-30

Endophys Blood Pressure Monitor model BPM-30 is an FDA 510(k)-cleared medical device (K231586) manufactured by Endophys Technologies, LLC. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 2, 2023. Regulation: 8.