SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS

SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS is an FDA 510(k)-cleared medical device (K900512) manufactured by Pacesetter Systems. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 24, 1990. Regulation: 8.