MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM

MODEL 263 SPECTRASCAN(TM) HOLTER ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K896862) manufactured by Del Mar Avionics. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 17, 1990. Regulation: 8.