BiliLux
K-Number: K172656 · 2018-05-01
ApplicantDraeger Medical Systems, Inc.
Decision Date2018-05-01
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
BiliLux is a medical device manufactured by Draeger Medical Systems, Inc.. It received FDA 510(k) clearance on 2018-05-01 under approval number K172656. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the BiliLux?
BiliLux is a medical device that received FDA 510(k) clearance on 2018-05-01. It is manufactured by Draeger Medical Systems, Inc.. The 510(k) number is K172656.
When was BiliLux approved by the FDA?
BiliLux received FDA 510(k) clearance on 2018-05-01, under approval number K172656.
What company makes BiliLux?
BiliLux is manufactured by Draeger Medical Systems, Inc..
What is the FDA product code for BiliLux?
The FDA product code for BiliLux is LBI.
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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.