FDA 510(k)

neoBLUE 細巧型 LED 光療系統

K 號：K160745 · 2016-12-12

決定日期2016-12-12

產品代碼LBI

諮詢委員會醫療設備規範文本翻譯如下： HO 注意：原文中未提供具體的醫療設備規範文本，因此上述翻譯僅為示例。請提供完整的規範文本以便進行準確翻譯。

決定相當於

器材摘要

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.

常見問題

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.

其他以 Natus Medical Incorporated 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K182178neoBLUE 紅外線光療系統 K182263RetCam 3；RetCam Shuttle；RetCam Portable K160305neoBLUE® LED光療系統

相關器械（代碼：LBI）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K251308SnugLit™ 穿戴式光療系統 (SNGL-01-US)Thera B Medical Products K243372BiliWrapGerium Medical, Ltd.K210289嬰兒光療設備Bistos Co., Ltd.K200031新生兒光療系統Avalon Biomedical (Shenzhen) Limited K190899比利-胡特Little Sparrows Technologies, Inc.K182178neoBLUE 紅外線光療系統Natus Medical Incorporated

官方來源

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