neoBLUE compact LED Phototherapy System
K-Number: K160745 · 2016-12-12
ApplicantNatus Medical Incorporated
Decision Date2016-12-12
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
neoBLUE compact LED Phototherapy System is a medical device manufactured by Natus Medical Incorporated. It received FDA 510(k) clearance on 2016-12-12 under approval number K160745. 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 compact LED Phototherapy System?
neoBLUE compact LED Phototherapy System is a medical device that received FDA 510(k) clearance on 2016-12-12. It is manufactured by Natus Medical Incorporated. The 510(k) number is K160745.
When was neoBLUE compact LED Phototherapy System approved by the FDA?
neoBLUE compact LED Phototherapy System received FDA 510(k) clearance on 2016-12-12, under approval number K160745.
What company makes neoBLUE compact LED Phototherapy System?
neoBLUE compact LED Phototherapy System is manufactured by Natus Medical Incorporated.
What is the FDA product code for neoBLUE compact LED Phototherapy System?
The FDA product code for neoBLUE compact LED Phototherapy System is LBI.
Related Clinical Trials
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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.