SYSTEM V.HEART RATE/RESPIR. RATE MONIT.

SYSTEM V.HEART RATE/RESPIR. RATE MONIT. is an FDA 510(k)-cleared medical device (K820114) 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 February 11, 1982. Regulation: 8.