Tumark for Eviva, Tumark for Brevera
K-Number: K182082 · 2018-10-31
ApplicantSomatex Medical Technologies GmbH
Decision Date2018-10-31
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Tumark for Eviva, Tumark for Brevera is a medical device manufactured by Somatex Medical Technologies GmbH. It received FDA 510(k) clearance on 2018-10-31 under approval number K182082. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Tumark for Eviva, Tumark for Brevera?
Tumark for Eviva, Tumark for Brevera is a medical device that received FDA 510(k) clearance on 2018-10-31. It is manufactured by Somatex Medical Technologies GmbH. The 510(k) number is K182082.
When was Tumark for Eviva, Tumark for Brevera approved by the FDA?
Tumark for Eviva, Tumark for Brevera received FDA 510(k) clearance on 2018-10-31, under approval number K182082.
What company makes Tumark for Eviva, Tumark for Brevera?
Tumark for Eviva, Tumark for Brevera is manufactured by Somatex Medical Technologies GmbH.
What is the FDA product code for Tumark for Eviva, Tumark for Brevera?
The FDA product code for Tumark for Eviva, Tumark for Brevera is NEU.
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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.