FDA 510(k)

mmRNA appliance

Номер K: K210203 · 2021-08-19

ЗаявительVivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)

Дата решения2021-08-19

Код продуктаLRK

Консультативный комитетDE

РешениеSubstantially Equivalent

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Связанные устройства (Код: LRK)

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLC K261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLC K261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

Официальный источник

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