MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)

MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991) is an FDA 510(k)-cleared medical device (K982277) manufactured by Nova Biomedical Corp.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 21, 1998. Regulation: 8.