PENRITH ELETTRA ULTRASOUND SYSTEM

PENRITH ELETTRA ULTRASOUND SYSTEM is an FDA 510(k)-cleared medical device (K100598) manufactured by Penrith Corporation. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2010. Regulation: 8.