FDA 510(k)

mRNA 裝置

K 號：K210203 · 2021-08-19

申請人Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I)

決定日期2021-08-19

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

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.

常見問題

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.

相關器械（代碼：LRK）

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官方來源

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器材摘要

常見問題

相關臨床試驗

相關器械（代碼：LRK）

官方來源