MYLAB 15 / MYLAB 20, MODEL 2700

MYLAB 15 / MYLAB 20, MODEL 2700 is an FDA 510(k)-cleared medical device (K043588) manufactured by Pie Medical. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 24, 2005. Regulation: 8.