EP Granules BVF
K-Number: K180853 · 2018-08-06
ApplicantElute, Inc.
Decision Date2018-08-06
Product CodeMQV
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
EP Granules BVF is a medical device manufactured by Elute, Inc.. It received FDA 510(k) clearance on 2018-08-06 under approval number K180853. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EP Granules BVF?
EP Granules BVF is a medical device that received FDA 510(k) clearance on 2018-08-06. It is manufactured by Elute, Inc.. The 510(k) number is K180853.
When was EP Granules BVF approved by the FDA?
EP Granules BVF received FDA 510(k) clearance on 2018-08-06, under approval number K180853.
What company makes EP Granules BVF?
EP Granules BVF is manufactured by Elute, Inc..
What is the FDA product code for EP Granules BVF?
The FDA product code for EP Granules BVF is MQV.
Other Devices by Elute, Inc.
Related Devices (Code: MQV)
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.