ETHYLENE OXIDE STERILIZ. PARAMETRIC REL.

ETHYLENE OXIDE STERILIZ. PARAMETRIC REL. is an FDA 510(k)-cleared medical device (K822240) manufactured by American Mcgaw. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 29, 1982. Regulation: 8.