COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT.

COMPUTER ASSISTED ARCHIVAL TECH. PHYSIOLOGY STAT. is an FDA 510(k)-cleared medical device (K931900) manufactured by Archival Technologies, 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 March 10, 1994. Regulation: 8.