FDA 510(k)

Stela 胶囊系統

K 號：K222583 · 2022-10-28

決定日期2022-10-28

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Stela Capsule System is the device name listed in this FDA 510(k) record. The listed applicant is Sdi Limited. It received FDA 510(k) clearance on 2022-10-28 under 510(k) number K222583. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stela Capsule System?

Stela Capsule System is a medical device that received FDA 510(k) clearance on 2022-10-28. The listed applicant is Sdi Limited. The 510(k) number is K222583.

When did Stela Capsule System receive FDA 510(k) clearance?

Stela Capsule System received FDA 510(k) clearance on 2022-10-28, under 510(k) number K222583.

Who is the listed applicant for Stela Capsule System?

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

What is the FDA product code for Stela Capsule System?

The FDA product code for Stela Capsule System is EBF.

其他以 Sdi Limited 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。

K222581Stela自動混和系統 K214118Riva Cem Automix K191656Zipbond K172047Riva 星

相關器械（代碼：EBF）

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。

K262982Core·it雙用式醫療設備規範文本Spident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695流動性修復材質（KP-Flow LF，KP-Flow MF，KP-Flow HF）Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus 填充劑；Tetric plus 流動劑Ivoclar Vivadent, Inc.K262228超越大量填充濃縮複合材料Ultradent Products, Inc.K261246SRGC-06GC America, Inc.

官方來源

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