FDA 510(k)

DeltaFil, DeltaFil Conditioner

K号: K213201 · 2022-06-01

申请人DMG Chemisch-Pharmazeutische Fabrik GmbH

决定日期2022-06-01

产品代码EMA

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决定实质等同

器械摘要

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.

常见问题

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.

列明DMG Chemisch-Pharmazeutische Fabrik GmbH为申报人的其他记录

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K183337LuxaCrown，色号 A1，A2，A3，A3.5；LuxaCrown B1，B3，C2，D2

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