PATIENT HEATER SYSTEM, MODEL PH112

PATIENT HEATER SYSTEM, MODEL PH112 is an FDA 510(k)-cleared medical device (K772015) manufactured by Carolina Medical Electronics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 14, 1977. Regulation: 8.