CARDIOMETRICS FLOWIRE & FLOMAP

CARDIOMETRICS FLOWIRE & FLOMAP is an FDA 510(k)-cleared medical device (K932536) 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 September 27, 1993. Regulation: 8.