SLEEP SYSTEM FOR CLINICS & RESEARCH

SLEEP SYSTEM FOR CLINICS & RESEARCH is an FDA 510(k)-cleared medical device (K955841) manufactured by Compumedics Ptd , Ltd.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 10, 1997. Regulation: 8.