FDA 510(k)

睡眠止鼾口器

K 號：K201484 · 2020-11-23

決定日期2020-11-23

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Somnos Anti-Snoring Mouth Guard is the device name listed in this FDA 510(k) record. The listed applicant is Koncept Innovators, LLC. It received FDA 510(k) clearance on 2020-11-23 under 510(k) number K201484. 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 Somnos Anti-Snoring Mouth Guard?

Somnos Anti-Snoring Mouth Guard is a medical device that received FDA 510(k) clearance on 2020-11-23. The listed applicant is Koncept Innovators, LLC. The 510(k) number is K201484.

When did Somnos Anti-Snoring Mouth Guard receive FDA 510(k) clearance?

Somnos Anti-Snoring Mouth Guard received FDA 510(k) clearance on 2020-11-23, under 510(k) number K201484.

Who is the listed applicant for Somnos Anti-Snoring Mouth Guard?

The FDA 510(k) record lists Koncept Innovators, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Somnos Anti-Snoring Mouth Guard?

The FDA product code for Somnos Anti-Snoring Mouth Guard is LRK.

其他以 Koncept Innovators, LLC 為申請人之記錄

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K181099亮盾

相關器械（代碼：LRK）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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