NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101

NEUROTRONICS POLYSOMNOGRAPHY SYSTEM 101 is an FDA 510(k)-cleared medical device (K971803) manufactured by Neurotronics, 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 November 11, 1997. Regulation: 8.