FDA 510(k)

Aster

K 號：K254182 · 2026-02-26

決定日期2026-02-26

產品代碼KWQ

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決定相當於

器材摘要

Aster is the device name listed in this FDA 510(k) record. The listed applicant is Osteonic Co., Ltd.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K254182. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Aster?

Aster is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Osteonic Co., Ltd.. The 510(k) number is K254182.

When did Aster receive FDA 510(k) clearance?

Aster received FDA 510(k) clearance on 2026-02-26, under 510(k) number K254182.

Who is the listed applicant for Aster?

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

What is the FDA product code for Aster?

The FDA product code for Aster is KWQ.

其他以 Osteonic Co., Ltd. 為申請人之記錄

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相關器械（代碼：KWQ）

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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