FDA 510(k)

下頜前移設備 L07

K 號：K251628 · 2025-10-22

決定日期2025-10-22

產品代碼LRK

諮詢委員會DE

決定相當於

器材摘要

Mandibular Advancement Device L07 is the device name listed in this FDA 510(k) record. The listed applicant is Dcstar, Inc.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251628. 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 Mandibular Advancement Device L07?

Mandibular Advancement Device L07 is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Dcstar, Inc.. The 510(k) number is K251628.

When did Mandibular Advancement Device L07 receive FDA 510(k) clearance?

Mandibular Advancement Device L07 received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251628.

Who is the listed applicant for Mandibular Advancement Device L07?

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

What is the FDA product code for Mandibular Advancement Device L07?

The FDA product code for Mandibular Advancement Device L07 is LRK.

其他以 Dcstar, Inc. 為申請人之記錄

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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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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