ENVIRONMENTAL CONTROL UNIT MODEL 7000

ENVIRONMENTAL CONTROL UNIT MODEL 7000 is an FDA 510(k)-cleared medical device (K901028) manufactured by Baylor Biomedical Services. This device is classified under the Physical Medicine specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 12, 1990. Regulation: 8.