FDA 510(k)

DIAFIL & DIAFIL膠囊

K 號：K192510 · 2020-03-20

決定日期2020-03-20

產品代碼EBF

諮詢委員會DE

決定相當於

器材摘要

DIAFIL & DIAFIL Capsule is the device name listed in this FDA 510(k) record. The listed applicant is DiaDent Group International. It received FDA 510(k) clearance on 2020-03-20 under 510(k) number K192510. 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 DIAFIL & DIAFIL Capsule?

DIAFIL & DIAFIL Capsule is a medical device that received FDA 510(k) clearance on 2020-03-20. The listed applicant is DiaDent Group International. The 510(k) number is K192510.

When did DIAFIL & DIAFIL Capsule receive FDA 510(k) clearance?

DIAFIL & DIAFIL Capsule received FDA 510(k) clearance on 2020-03-20, under 510(k) number K192510.

Who is the listed applicant for DIAFIL & DIAFIL Capsule?

FDA 510(k) 記錄將 DiaDent Group International 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for DIAFIL & DIAFIL Capsule?

The FDA product code for DIAFIL & DIAFIL Capsule is EBF.

其他以 DiaDent Group International 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。

K254152Dia-X Sil Light Body K254142Dia-X Sil Heavy Body K261166DIA-CEM K261093DIAFIL K261071DIAFIL 大量流量（經濟包裝）；DIAFIL 大量流量（補充包裝）；DIAFIL 大量流量（0.5g）K254112迪亞-X 靜脈針

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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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官方來源

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