FDA 510(k)

K5

K 號：K233805 · 2024-09-03

申請人Osstem Implant Co., Ltd. Chair Business

決定日期2024-09-03

產品代碼EIA

諮詢委員會DE

決定相當於

器材摘要

K5 is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd. Chair Business. It received FDA 510(k) clearance on 2024-09-03 under 510(k) number K233805. The device is classified under product code EIA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the K5?

K5 is a medical device that received FDA 510(k) clearance on 2024-09-03. The listed applicant is Osstem Implant Co., Ltd. Chair Business. The 510(k) number is K233805.

When did K5 receive FDA 510(k) clearance?

K5 received FDA 510(k) clearance on 2024-09-03, under 510(k) number K233805.

Who is the listed applicant for K5?

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

What is the FDA product code for K5?

The FDA product code for K5 is EIA.

相關器械（代碼：EIA）

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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