VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300

VITALMAX 800 PLUS/VITALMAX 810 PLUS/MINIPACK 300 is an FDA 510(k)-cleared medical device (K945385) manufactured by Pace Tech, 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 January 30, 1995. Regulation: 8.