SAFERSONIC SONOGRAPHY COVER

SAFERSONIC SONOGRAPHY COVER is an FDA 510(k)-cleared medical device (K092858) manufactured by Safersonic Medizinprodukte GmbH. 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 9, 2009. Regulation: 8.