MicrO2 OSA Device with Micro-Recorder

MicrO2 OSA Device with Micro-Recorder is an FDA 510(k)-cleared medical device (K161624) manufactured by Microdental, Inc.. This device is classified under the Dental specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 6, 2016. Regulation: 8.