FDA 510(k)

Signum不透明F

K 號：K230644 · 2023-09-07

決定日期2023-09-07

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

Signum opaque F is the device name listed in this FDA 510(k) record. The listed applicant is Kulzer, LLC. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K230644. 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 Signum opaque F?

Signum opaque F is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Kulzer, LLC. The 510(k) number is K230644.

When did Signum opaque F receive FDA 510(k) clearance?

Signum opaque F received FDA 510(k) clearance on 2023-09-07, under 510(k) number K230644.

Who is the listed applicant for Signum opaque F?

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

What is the FDA product code for Signum opaque F?

The FDA product code for Signum opaque F is EBF.

其他以 Kulzer, LLC 為申請人之記錄

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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。

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