LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED

LABSONICS MAMM-O-MATE MODEL NO. 918084-1, MODIFIED is an FDA 510(k)-cleared medical device (K905522) manufactured by Laboratory Equipment Corp.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 10, 1991. Regulation: 8.