VisCalor bulk
K-Number: K190453 · 2019-04-11
ApplicantVoco GmbH
Decision Date2019-04-11
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
VisCalor bulk is a medical device manufactured by Voco GmbH. It received FDA 510(k) clearance on 2019-04-11 under approval number K190453. 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 VisCalor bulk?
VisCalor bulk is a medical device that received FDA 510(k) clearance on 2019-04-11. It is manufactured by Voco GmbH. The 510(k) number is K190453.
When was VisCalor bulk approved by the FDA?
VisCalor bulk received FDA 510(k) clearance on 2019-04-11, under approval number K190453.
What company makes VisCalor bulk?
VisCalor bulk is manufactured by Voco GmbH.
What is the FDA product code for VisCalor bulk?
The FDA product code for VisCalor bulk 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.