CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT

CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT is an FDA 510(k)-cleared medical device (K933320) manufactured by Cardio Metrics, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 16, 1994. Regulation: 8.