FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS

FAILSAFE - PORTABLE INFECTION CONTROL SYSTEMS is an FDA 510(k)-cleared medical device (K022260) manufactured by Isolation Systems, Inc.. This device is classified under the General Hospital specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 28, 2002. Regulation: 8.