TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES

TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES is an FDA 510(k)-cleared medical device (K043278) manufactured by Teratech 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 December 12, 2004. Regulation: 8.