FDA 510(k)

C.C. LIFE 21

K 號：K213295 · 2022-11-17

決定日期2022-11-17

產品代碼PBX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

C.C. LIFE 21 is the device name listed in this FDA 510(k) record. The listed applicant is 21 Equipment S.R.L.. It received FDA 510(k) clearance on 2022-11-17 under 510(k) number K213295. The device is classified under product code PBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the C.C. LIFE 21?

C.C. LIFE 21 is a medical device that received FDA 510(k) clearance on 2022-11-17. The listed applicant is 21 Equipment S.R.L.. The 510(k) number is K213295.

When did C.C. LIFE 21 receive FDA 510(k) clearance?

C.C. LIFE 21 received FDA 510(k) clearance on 2022-11-17, under 510(k) number K213295.

Who is the listed applicant for C.C. LIFE 21?

The FDA 510(k) record lists 21 Equipment S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for C.C. LIFE 21?

The FDA product code for C.C. LIFE 21 is PBX.

其他以 21 Equipment S.R.L. 為申請人之記錄

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K230459C.C. Life 21

相關器械（代碼：PBX）

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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