Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
FDA 510(k) K172859 · Prosomnous Sleep Technologies
510(k) numberK172859
Submission
- Device name
- Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
- Applicant
- Prosomnous Sleep Technologies
Pleasanton, CA, US - Received
- September 20, 2017
- Decision date
- November 22, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PLC – Sleep Appliances With Patient Monitoring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.5570
- Specialty
- Dental
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.
Other 510(k)s with product code PLC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254304 | iNOS intraoral biosensorPLC · Traditional | Achaemenid, LLC | 08/25/2026SE |
| K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA)PLC · Traditional | Prosomnus Sleep Technologies | 04/06/2026SE |
| K233497 | Rest Assure SystemPLC · Traditional | Somnomed, Inc. | 10/03/2024SE |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracPLC · Traditional | Residential Home Sleep Services | 04/10/2020SE |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorPLC · Traditional | Mark Abramson, D.D.S., Inc. | 04/19/2019SE |
| K170606 | Acrylic Herbst Appliance with Micro-RecorderPLC · Traditional | Gergen'S Orthodontic Lab | 11/16/2017SE |
| K161624 | MicrO2 OSA Device with Micro-RecorderPLC · Traditional | Microdental, Inc. | 11/07/2016SE |
| K160239 | Tap 3, Tap 1PLC · Traditional | Airway Management, Inc. | 08/10/2016SE |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac…PLC · Traditional | Somnomed, Inc. | 06/18/2015SE |
Questions and answers
When was Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder cleared by the FDA?
Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder (K172859) received a 510(k) decision of Substantially Equivalent on November 22, 2017, 63 days after the submission was received.
What is the product code of K172859?
The FDA product code is PLC – Sleep Appliances With Patient Monitoring, a Class II (moderate risk) device regulated under 21 CFR 872.5570.