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FDA 510(k)

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)

K-Number: K203606 · 2021-03-10

ApplicantMeris Investment Group
Decision Date2021-03-10
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is the device name listed in this FDA 510(k) record. The listed applicant is Meris Investment Group. It received FDA 510(k) clearance on 2021-03-10 under 510(k) number K203606. 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 Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) is a medical device that received FDA 510(k) clearance on 2021-03-10. The listed applicant is Meris Investment Group. The 510(k) number is K203606.

When did Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) receive FDA 510(k) clearance?

Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) received FDA 510(k) clearance on 2021-03-10, under 510(k) number K203606.

Who is the listed applicant for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

The FDA 510(k) record lists Meris Investment Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA)?

The FDA product code for Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) 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.

NCT04092660Increasing the Use of an Anti-snoring Mouth Guard (Mandibular Advancement Appliance) to Prevent Upper Airway Collapse During Sleep in Patients With Obstructive Sleep Apnoea.RECRUITINGNCT05477719Effect of Compression Stockings on the Number of Apneas/Hypopneas Per Hour of Sleep in Patients With Syndrome Obstructive Sleep Apnea/Hypopnea as Compared to no TreatmentCOMPLETEDNCT05939934Impact of the Mandibular Advancement Device on Sleep Apnea During CPAP WithdrawalRECRUITINGNCT06576310Predictive Factors for Occlusal Changes in Obstructive Sleep Apnea Treatment With Mandibular Advancement ApplianceRECRUITINGNCT06970171Acceptance of Mandibular Advancement DevicesENROLLING_BY_INVITATIONNCT07074288Obstructive Sleep Apnea Non-PAP Outcomes and Viable AlternativesRECRUITING

Other records listing Meris Investment Group 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.

K230495Serena Sleep Night Guard

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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