INSTA-PULSE HEART RATE MONITOR

INSTA-PULSE HEART RATE MONITOR is an FDA 510(k)-cleared medical device (K781387) manufactured by Bio Sig 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 September 19, 1978. Regulation: 8.