FDA 510(k)

TempoCem 清晰

K号: K160443 · 2016-09-30

决定日期2016-09-30

产品代码EMA

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决定实质等同

器械摘要

TempoCem Clear is the device name listed in this FDA 510(k) record. The listed applicant is Dmg USA, Inc.. It received FDA 510(k) clearance on 2016-09-30 under 510(k) number K160443. 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 TempoCem Clear?

TempoCem Clear is a medical device that received FDA 510(k) clearance on 2016-09-30. The listed applicant is Dmg USA, Inc.. The 510(k) number is K160443.

When did TempoCem Clear receive FDA 510(k) clearance?

TempoCem Clear received FDA 510(k) clearance on 2016-09-30, under 510(k) number K160443.

Who is the listed applicant for TempoCem Clear?

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

What is the FDA product code for TempoCem Clear?

The FDA product code for TempoCem Clear is EMA.

列明Dmg USA, Inc.为申报人的其他记录

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