everX Flow
K-Number: K192260 · 2019-11-22
ApplicantGC America, Inc.
Decision Date2019-11-22
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
everX Flow is a medical device manufactured by GC America, Inc.. It received FDA 510(k) clearance on 2019-11-22 under approval number K192260. 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 everX Flow?
everX Flow is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by GC America, Inc.. The 510(k) number is K192260.
When was everX Flow approved by the FDA?
everX Flow received FDA 510(k) clearance on 2019-11-22, under approval number K192260.
What company makes everX Flow?
everX Flow is manufactured by GC America, Inc..
What is the FDA product code for everX Flow?
The FDA product code for everX Flow 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.