FluoroCal
K-Number: K182917 · 2019-11-18
ApplicantBisco, Inc.
Decision Date2019-11-18
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
FluoroCal is a medical device manufactured by Bisco, Inc.. It received FDA 510(k) clearance on 2019-11-18 under approval number K182917. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the FluoroCal?
FluoroCal is a medical device that received FDA 510(k) clearance on 2019-11-18. It is manufactured by Bisco, Inc.. The 510(k) number is K182917.
When was FluoroCal approved by the FDA?
FluoroCal received FDA 510(k) clearance on 2019-11-18, under approval number K182917.
What company makes FluoroCal?
FluoroCal is manufactured by Bisco, Inc..
What is the FDA product code for FluoroCal?
The FDA product code for FluoroCal is LBH.
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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.