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FDA 510(k)

智慧-C

K 號：K190024 · 2019-09-27

申請人Turner Imaging Systems, Inc.
決定日期2019-09-27
產品代碼OXO
諮詢委員會RA
決定相當於

器材摘要

Smart-C is the device name listed in this FDA 510(k) record. The listed applicant is Turner Imaging Systems, Inc.. It received FDA 510(k) clearance on 2019-09-27 under 510(k) number K190024. The device is classified under product code OXO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Smart-C?

Smart-C is a medical device that received FDA 510(k) clearance on 2019-09-27. The listed applicant is Turner Imaging Systems, Inc.. The 510(k) number is K190024.

When did Smart-C receive FDA 510(k) clearance?

Smart-C received FDA 510(k) clearance on 2019-09-27, under 510(k) number K190024.

Who is the listed applicant for Smart-C?

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

What is the FDA product code for Smart-C?

The FDA product code for Smart-C is OXO.

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相關器械（代碼：OXO）

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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