FDA 510(k)

TempoCem Clear

K-Number: K160443 · 2016-09-30

Decision Date2016-09-30

Product CodeEMA

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Other records listing Dmg USA, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.