neoBLUE® LED Phototherapy System
K-Number: K160305 · 2016-05-27
ApplicantNatus Medical Incorporated
Decision Date2016-05-27
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
neoBLUE® LED Phototherapy System is a medical device manufactured by Natus Medical Incorporated. It received FDA 510(k) clearance on 2016-05-27 under approval number K160305. 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 neoBLUE® LED Phototherapy System?
neoBLUE® LED Phototherapy System is a medical device that received FDA 510(k) clearance on 2016-05-27. It is manufactured by Natus Medical Incorporated. The 510(k) number is K160305.
When was neoBLUE® LED Phototherapy System approved by the FDA?
neoBLUE® LED Phototherapy System received FDA 510(k) clearance on 2016-05-27, under approval number K160305.
What company makes neoBLUE® LED Phototherapy System?
neoBLUE® LED Phototherapy System is manufactured by Natus Medical Incorporated.
What is the FDA product code for neoBLUE® LED Phototherapy System?
The FDA product code for neoBLUE® LED Phototherapy System is LBI.
Other Devices by Natus Medical Incorporated
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K182178neoBLUE blanket LED Phototherapy SystemNatus Medical Incorporated
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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.