PORTABLE SLEEP DATA RECORDER (PSDR)

PORTABLE SLEEP DATA RECORDER (PSDR) is an FDA 510(k)-cleared medical device (K033402) manufactured by Pro-Tech Services, Inc.. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on June 29, 2004. Regulation: 8.