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FDA 510(k)

mmRNA appliance

K-Number: K210203 · 2021-08-19

ApplicantVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)
Decision Date2021-08-19
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

mmRNA appliance is the device name listed in this FDA 510(k) record. The listed applicant is Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I). It received FDA 510(k) clearance on 2021-08-19 under 510(k) number K210203. 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 mmRNA appliance?

mmRNA appliance is a medical device that received FDA 510(k) clearance on 2021-08-19. The listed applicant is Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I). The 510(k) number is K210203.

When did mmRNA appliance receive FDA 510(k) clearance?

mmRNA appliance received FDA 510(k) clearance on 2021-08-19, under 510(k) number K210203.

Who is the listed applicant for mmRNA appliance?

The FDA 510(k) record lists Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for mmRNA appliance?

The FDA product code for mmRNA appliance 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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