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FDA 510(k)

neoBLUE blanket LED Phototherapy System

K-Number: K182178 · 2018-12-13

ApplicantNatus Medical Incorporated
Decision Date2018-12-13
Product CodeLBI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

neoBLUE blanket LED Phototherapy System is a medical device manufactured by Natus Medical Incorporated. It received FDA 510(k) clearance on 2018-12-13 under approval number K182178. 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 blanket LED Phototherapy System?

neoBLUE blanket LED Phototherapy System is a medical device that received FDA 510(k) clearance on 2018-12-13. It is manufactured by Natus Medical Incorporated. The 510(k) number is K182178.

When was neoBLUE blanket LED Phototherapy System approved by the FDA?

neoBLUE blanket LED Phototherapy System received FDA 510(k) clearance on 2018-12-13, under approval number K182178.

What company makes neoBLUE blanket LED Phototherapy System?

neoBLUE blanket LED Phototherapy System is manufactured by Natus Medical Incorporated.

What is the FDA product code for neoBLUE blanket LED Phototherapy System?

The FDA product code for neoBLUE blanket LED Phototherapy System is LBI.

Related Clinical Trials

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Other Devices by Natus Medical Incorporated

K160745neoBLUE compact LED Phototherapy System K160305neoBLUE® LED Phototherapy System K182263RetCam 3 ; RetCam Shuttle ; RetCam Portable

Related Devices (Code: LBI)

K160745neoBLUE compact LED Phototherapy SystemNatus Medical Incorporated K160238Airborne Phototherapy LightInternational Biomedical K160305neoBLUE® LED Phototherapy SystemNatus Medical Incorporated K170585SkylifeNeolight, LLC K163526Bilicocoon™ Phototherapy SystemNeomedlight K172656BiliLuxDraeger Medical Systems, Inc.

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.

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