OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor

K181571 is the FDA 510(k) clearance record for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor, a class II device, cleared for Mark Abramson, D.D.S., Inc. on 2019-04-19 under FDA product code PLC (Sleep Appliances With Patient Monitoring). FDA's definition for product code PLC reads: "For the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older while also measuring patient compliance to oral appliance therapy". FDA records list 2 510(k) clearances for Mark Abramson, D.D.S., Inc., from 2003-08-26 to 2019-04-19. As of 2026-09-10, FDA records show no recalls naming K181571.