LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2)

LASERFLO(R) BLOOD PERFUSION MONITOR (MODEL BPM2) is an FDA 510(k)-cleared medical device (K911763) manufactured by Vasamedics, 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 August 12, 1991. Regulation: 8.