FDA 510(k)

neoBLUE compact LED Phototherapy System

K番号: K160745 · 2016-12-12

決定日2016-12-12

製品コードLBI

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

neoBLUE compact 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 2016-12-12 under 510(k) number K160745. The device is classified under product code LBI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

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. The listed applicant is Natus Medical Incorporated. The 510(k) number is K160745.

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

neoBLUE compact LED Phototherapy System received FDA 510(k) clearance on 2016-12-12, under 510(k) number K160745.

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

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

申請者としてNatus Medical Incorporatedを記載するその他の記録

K182178neoBLUE blanket LED Phototherapy System K182263レットキャム 3；レットキャムシャトル；レットキャムポータブル K160305neoBLUE® LED Phototherapy System

公式ソース

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