510(k) clearances for Sleep Appliances With Patient Monitoring
9 on file
- Prosomnus Sleep TechnologiesApr 6, 2026
K252765 · ProSomnus RPMO2 OSA Device (RPMO2 OSA)
- Somnomed, Inc.Oct 3, 2024
K233497 · Rest Assure System
- Residential Home Sleep ServicesApr 10, 2020
K190353 · Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac
- Mark Abramson, D.D.S., Inc.Apr 19, 2019
K181571 · OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
- Prosomnous Sleep TechnologiesNov 22, 2017
K172859 · Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
- Gergen'S Orthodontic LabNov 16, 2017
K170606 · Acrylic Herbst Appliance with Micro-Recorder
- Microdental, Inc.Nov 7, 2016
K161624 · MicrO2 OSA Device with Micro-Recorder
- Airway Management, Inc.Aug 10, 2016
K160239 · TAP 3, TAP 1
- Somnomed, Inc.Jun 18, 2015
K150369 · SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder