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FDA 510(k)

Express 4 Sleep appliance/CPAP Sidekick appliance

K-Number: K173856 · 2018-06-26

ApplicantMoses Appliances, LLC
Decision Date2018-06-26
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Express 4 Sleep appliance/CPAP Sidekick appliance is the device name listed in this FDA 510(k) record. The listed applicant is Moses Appliances, LLC. It received FDA 510(k) clearance on 2018-06-26 under 510(k) number K173856. 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 Express 4 Sleep appliance/CPAP Sidekick appliance?

Express 4 Sleep appliance/CPAP Sidekick appliance is a medical device that received FDA 510(k) clearance on 2018-06-26. The listed applicant is Moses Appliances, LLC. The 510(k) number is K173856.

When did Express 4 Sleep appliance/CPAP Sidekick appliance receive FDA 510(k) clearance?

Express 4 Sleep appliance/CPAP Sidekick appliance received FDA 510(k) clearance on 2018-06-26, under 510(k) number K173856.

Who is the listed applicant for Express 4 Sleep appliance/CPAP Sidekick appliance?

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

What is the FDA product code for Express 4 Sleep appliance/CPAP Sidekick appliance?

The FDA product code for Express 4 Sleep appliance/CPAP Sidekick appliance is LRK.

Related Clinical Trials

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.

NCT07677332Mandibular Advancement Device (MAD) and Continuous Positive Airway Pressure (CPAP) for Treatment of Adult Patients Diagnosed With Moderate Obstructive Sleep ApneaNOT_YET_RECRUITING

Related Devices (Code: LRK)

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.

K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLCK253845Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB)Ram.Shaw Pte. , Ltd.

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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