VITAL STATISTICS SYSTEM (O-CATH ACCESSORY)

VITAL STATISTICS SYSTEM (O-CATH ACCESSORY) is an FDA 510(k)-cleared medical device (K964978) manufactured by Quinton, 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 May 20, 1997. Regulation: 8.