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FDA 510(k)

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring

K-Number: K202529 · 2020-11-20

ApplicantProsomnus Sleep Technologies, Inc.
Decision Date2020-11-20
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is a medical device manufactured by Prosomnus Sleep Technologies, Inc.. It received FDA 510(k) clearance on 2020-11-20 under approval number K202529. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring?

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is a medical device that received FDA 510(k) clearance on 2020-11-20. It is manufactured by Prosomnus Sleep Technologies, Inc.. The 510(k) number is K202529.

When was ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring approved by the FDA?

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring received FDA 510(k) clearance on 2020-11-20, under approval number K202529.

What company makes ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring?

ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is manufactured by Prosomnus Sleep Technologies, Inc..

What is the FDA product code for ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring?

The FDA product code for ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring is LRK.

Related Clinical Trials

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Related PubMed Literature

PMID: 42181028 Systematic biocompatibility assessment of 4-µm surface silicone implants. Biomaterials and biosystems (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42065230 The need of innovation and of preservation of well-established techniques in the era of MDR for improving outcomes. EFORT open reviews (2026)

Related Devices (Code: LRK)

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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.

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