DEFIBRILLATOR ANALYZER MODEL QED-5

DEFIBRILLATOR ANALYZER MODEL QED-5 is an FDA 510(k)-cleared medical device (K904159) manufactured by Bio-Tek Instruments, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 17, 1991. Regulation: 8.