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FDA 510(k)

Aniti-Snore Mouthguard+

K-Number: K231138 · 2024-01-16

ApplicantOscimed SA
Decision Date2024-01-16
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Aniti-Snore Mouthguard+ is the device name listed in this FDA 510(k) record. The listed applicant is Oscimed SA. It received FDA 510(k) clearance on 2024-01-16 under 510(k) number K231138. 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 Aniti-Snore Mouthguard+?

Aniti-Snore Mouthguard+ is a medical device that received FDA 510(k) clearance on 2024-01-16. The listed applicant is Oscimed SA. The 510(k) number is K231138.

When did Aniti-Snore Mouthguard+ receive FDA 510(k) clearance?

Aniti-Snore Mouthguard+ received FDA 510(k) clearance on 2024-01-16, under 510(k) number K231138.

Who is the listed applicant for Aniti-Snore Mouthguard+?

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

What is the FDA product code for Aniti-Snore Mouthguard+?

The FDA product code for Aniti-Snore Mouthguard+ is LRK.

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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