AIR-SHIELDS HEART RATE MONITOR

AIR-SHIELDS HEART RATE MONITOR is an FDA 510(k)-cleared medical device (K792117) manufactured by Narco Air-Shields. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 12, 1979. Regulation: 8.