
Mark Abramson, D.D.S., Inc.
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OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor is an FDA 510(k)-cleared medical device (K181571) manufactured by Mark Abramson, D.D.S., 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 April 18, 2019. Regulation: 8.