PE-3000 PULSE RATE MONITOR

PE-3000 PULSE RATE MONITOR is an FDA 510(k)-cleared medical device (K854198) manufactured by Quantum Life Systems, 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 12, 1986. Regulation: 8.