MODEL 1000 APC-ANGIOPLASTY PRESSURE

MODEL 1000 APC-ANGIOPLASTY PRESSURE is an FDA 510(k)-cleared medical device (K841493) manufactured by E.A. Fischione Instrument Mfg.. 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 10, 1984. Regulation: 8.