FDA 510(k)

Panthera 防打鼾 X3 裝置

K 號：K171576 · 2018-02-22

決定日期2018-02-22

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

The Panthera Anti-Snoring X3 Device is the device name listed in this FDA 510(k) record. The listed applicant is Panthera Dental, Inc.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K171576. 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 The Panthera Anti-Snoring X3 Device?

The Panthera Anti-Snoring X3 Device is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Panthera Dental, Inc.. The 510(k) number is K171576.

When did The Panthera Anti-Snoring X3 Device receive FDA 510(k) clearance?

The Panthera Anti-Snoring X3 Device received FDA 510(k) clearance on 2018-02-22, under 510(k) number K171576.

Who is the listed applicant for The Panthera Anti-Snoring X3 Device?

The FDA 510(k) record lists Panthera Dental, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for The Panthera Anti-Snoring X3 Device?

The FDA product code for The Panthera Anti-Snoring X3 Device is LRK.

其他以 Panthera Dental, Inc. 為申請人之記錄

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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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