GrandioSO x-tra
K-Number: K181312 · 2018-08-22
ApplicantVoco GmbH
Decision Date2018-08-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
GrandioSO x-tra is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2018-08-22 under approval number K181312. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the GrandioSO x-tra?
GrandioSO x-tra is a medical device that received FDA 510(k) clearance on 2018-08-22. It is manufactured by Voco GmbH. The 510(k) number is K181312.
When was GrandioSO x-tra approved by the FDA?
GrandioSO x-tra received FDA 510(k) clearance on 2018-08-22, under approval number K181312.
What company makes GrandioSO x-tra?
GrandioSO x-tra is manufactured by Voco GmbH.
What is the FDA product code for GrandioSO x-tra?
The FDA product code for GrandioSO x-tra is EBF.
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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.