FDA 510(k)

DeltaFil, DeltaFil 內容物

K 號：K213201 · 2022-06-01

申請人DMG Chemisch-Pharmazeutische Fabrik GmbH

決定日期2022-06-01

產品代碼EMA

諮詢委員會DE

決定相當於

器材摘要

DeltaFil, DeltaFil Conditioner is the device name listed in this FDA 510(k) record. The listed applicant is DMG Chemisch-Pharmazeutische Fabrik GmbH. It received FDA 510(k) clearance on 2022-06-01 under 510(k) number K213201. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DeltaFil, DeltaFil Conditioner?

DeltaFil, DeltaFil Conditioner is a medical device that received FDA 510(k) clearance on 2022-06-01. The listed applicant is DMG Chemisch-Pharmazeutische Fabrik GmbH. The 510(k) number is K213201.

When did DeltaFil, DeltaFil Conditioner receive FDA 510(k) clearance?

DeltaFil, DeltaFil Conditioner received FDA 510(k) clearance on 2022-06-01, under 510(k) number K213201.

Who is the listed applicant for DeltaFil, DeltaFil Conditioner?

The FDA 510(k) record lists DMG Chemisch-Pharmazeutische Fabrik GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeltaFil, DeltaFil Conditioner?

The FDA product code for DeltaFil, DeltaFil Conditioner is EMA.

其他以 DMG Chemisch-Pharmazeutische Fabrik GmbH 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。

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相關器械（代碼：EMA）

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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