PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM.

PEDIA-TEMP(TM) LIQUID-CIRCULATING HYPO-HYPERTHERM. is an FDA 510(k)-cleared medical device (K902268) manufactured by Seabrook Medical Systems, Inc.. 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 June 20, 1990. Regulation: 8.