SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME

SAPPHIRE SERIES 1P, 1L, 2L, AND 2ME is an FDA 510(k)-cleared medical device (K903731) manufactured by Teca, Inc.. This device is classified under the Neurology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 3, 1991. Regulation: 8.