FDA 510(k)

星X-1、星X-2、星X PRO-1 及星X PRO-2

K 號：K212103 · 2021-08-30

決定日期2021-08-30

產品代碼MUH

諮詢委員會DE

決定相當於

器材摘要

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is the device name listed in this FDA 510(k) record. The listed applicant is Fona S.R.L. It received FDA 510(k) clearance on 2021-08-30 under 510(k) number K212103. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is a medical device that received FDA 510(k) clearance on 2021-08-30. The listed applicant is Fona S.R.L. The 510(k) number is K212103.

When did StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 receive FDA 510(k) clearance?

StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 received FDA 510(k) clearance on 2021-08-30, under 510(k) number K212103.

Who is the listed applicant for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?

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

What is the FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2?

The FDA product code for StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 is MUH.

其他以 Fona S.R.L 為申請人之記錄

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相關器械（代碼：MUH）

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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