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FDA 510(k)

Rest Assure System

K-Number: K233497 · 2024-10-03

ApplicantSomnomed, Inc.
Decision Date2024-10-03
Product CodePLC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Rest Assure System is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) number K233497. 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 Rest Assure System?

Rest Assure System is a medical device that received FDA 510(k) clearance on 2024-10-03. The listed applicant is Somnomed, Inc.. The 510(k) number is K233497.

When did Rest Assure System receive FDA 510(k) clearance?

Rest Assure System received FDA 510(k) clearance on 2024-10-03, under 510(k) number K233497.

Who is the listed applicant for Rest Assure System?

The FDA 510(k) record lists Somnomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Rest Assure System?

The FDA product code for Rest Assure System is PLC.

Other records listing Somnomed, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261366VirtusK183443SomnoDent AvantK162306SomnoDent ALPHA

Related Devices (Code: PLC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252765ProSomnus RPMO2 OSA Device (RPMO2 OSA)Prosomnus Sleep TechnologiesK190353Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTracResidential Home Sleep ServicesK181571OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient MonitorMark Abramson, D.D.S., Inc.K172859Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorderProsomnous Sleep TechnologiesK170606Acrylic Herbst Appliance with Micro-RecorderGergen'S Orthodontic LabK161624MicrO2 OSA Device with Micro-RecorderMicrodental, Inc.

Official Source

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

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