TempoCem Clear
K-Number: K160443 · 2016-09-30
ApplicantDmg USA, Inc.
Decision Date2016-09-30
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
TempoCem Clear is a medical device manufactured by Dmg USA, Inc.. It received FDA 510(k) clearance on 2016-09-30 under approval 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. It is manufactured by Dmg USA, Inc.. The 510(k) number is K160443.
When was TempoCem Clear approved by the FDA?
TempoCem Clear received FDA 510(k) clearance on 2016-09-30, under approval number K160443.
What company makes TempoCem Clear?
TempoCem Clear is manufactured by Dmg USA, Inc..
What is the FDA product code for TempoCem Clear?
The FDA product code for TempoCem Clear is EMA.
Other Devices by Dmg USA, Inc.
Related Devices (Code: EMA)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.