Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder

K-Number: K172859 · 2017-11-22

ApplicantProsomnous Sleep Technologies
Decision Date2017-11-22
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is a medical device manufactured by Prosomnous Sleep Technologies. It received FDA 510(k) clearance on 2017-11-22 under approval number K172859. The device is classified under product code PLC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is a medical device that received FDA 510(k) clearance on 2017-11-22. It is manufactured by Prosomnous Sleep Technologies. The 510(k) number is K172859.

When was Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder approved by the FDA?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder received FDA 510(k) clearance on 2017-11-22, under approval number K172859.

What company makes Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is manufactured by Prosomnous Sleep Technologies.

What is the FDA product code for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder?

The FDA product code for Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder is PLC.

Related Clinical Trials

NCT02193425 Reliability of the Human Brain Connectome COMPLETED NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT03288207 Tailoring Mobile Health Technology to Reduce Obesity and Improve Cardiovascular Health in Resource-Limited Neighborhood Environments RECRUITING NCT07611643 Bruxism Therapy of Facial Pain RECRUITING NCT04121923 Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea COMPLETED NCT07143838 Enhancing Slow Wave Sleep in Depression NOT_YET_RECRUITING

Related PubMed Literature

PMID: 40290478 Mental health apps in India: regulatory landscape and future directions. BJPsych international (2025)

Related Devices (Code: PLC)

K161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc. K160239TAP 3, TAP 1Airway Management, Inc. K170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic Lab K181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc. K190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep Services K233497Rest Assure SystemSomnomed, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑