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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 the device name listed in this FDA 510(k) record. The listed applicant is Natus Medical Incorporated. It received FDA 510(k) clearance on 2018-12-13 under 510(k) 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. The listed applicant is Natus Medical Incorporated. The 510(k) number is K182178.

When did neoBLUE blanket LED Phototherapy System receive FDA 510(k) clearance?

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

Who is the listed applicant for neoBLUE blanket LED Phototherapy System?

The FDA 510(k) record lists Natus Medical Incorporated as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Natus Medical Incorporated as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K182263RetCam 3 ; RetCam Shuttle ; RetCam PortableK160745neoBLUE compact LED Phototherapy SystemK160305neoBLUE® LED Phototherapy System

Related Devices (Code: LBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251308SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)Thera B Medical ProductsK243372BiliWrapGerium Medical, Ltd.K210289Infant Phototherapy EquipmentBistos Co., Ltd.K200031Neonatal Phototherapy SystemAvalon Biomedical (Shenzhen) LimitedK190899bili-hutLittle Sparrows Technologies, Inc.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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