NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)

NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS) is an FDA 510(k)-cleared medical device (K020300) manufactured by Syntermed, Inc.. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 22, 2002. Regulation: 8.