ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000)

ACCUFLO MONITORING SYSTEM (1800)/ ACCUFLO PROBE (8000) is an FDA 510(k)-cleared medical device (K963703) manufactured by International Biophysics Corp.. 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 7, 1998. Regulation: 8.