ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE

ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE is an FDA 510(k)-cleared medical device (K040142) manufactured by Adac Laboratories. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 5, 2004. Regulation: 8.