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FDA 510(k)

STarFix設計軟體 C0265

K 號:K231141 · 2023-09-08

申請人FHC, Inc.
決定日期2023-09-08
產品代碼QRI
諮詢委員會NE (請提供完整的英文描述,以便進行翻譯。)
決定相當於

器材摘要

STarFix Designer Software C0265 is the device name listed in this FDA 510(k) record. The listed applicant is FHC, Inc.. It received FDA 510(k) clearance on 2023-09-08 under 510(k) number K231141. The device is classified under product code QRI. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the STarFix Designer Software C0265?

STarFix Designer Software C0265 is a medical device that received FDA 510(k) clearance on 2023-09-08. The listed applicant is FHC, Inc.. The 510(k) number is K231141.

When did STarFix Designer Software C0265 receive FDA 510(k) clearance?

STarFix Designer Software C0265 received FDA 510(k) clearance on 2023-09-08, under 510(k) number K231141.

Who is the listed applicant for STarFix Designer Software C0265?

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

What is the FDA product code for STarFix Designer Software C0265?

The FDA product code for STarFix Designer Software C0265 is QRI.

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其他以 FHC, Inc. 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。

官方來源

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