FDA 510(k)

軟腭提升器

K 號：K222127 · 2022-10-24

決定日期2022-10-24

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Soft Palate Elevator is the device name listed in this FDA 510(k) record. The listed applicant is The Tmj Clinic PC. It received FDA 510(k) clearance on 2022-10-24 under 510(k) number K222127. 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 Soft Palate Elevator?

Soft Palate Elevator is a medical device that received FDA 510(k) clearance on 2022-10-24. The listed applicant is The Tmj Clinic PC. The 510(k) number is K222127.

When did Soft Palate Elevator receive FDA 510(k) clearance?

Soft Palate Elevator received FDA 510(k) clearance on 2022-10-24, under 510(k) number K222127.

Who is the listed applicant for Soft Palate Elevator?

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

What is the FDA product code for Soft Palate Elevator?

The FDA product code for Soft Palate Elevator is LRK.

其他以 The Tmj Clinic PC 為申請人之記錄

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K243752雙管赫斯特設備

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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