FDA 510(k)

Airborne光療燈

K 號：K160238 · 2016-06-14

決定日期2016-06-14

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

Airborne Phototherapy Light is the device name listed in this FDA 510(k) record. The listed applicant is International Biomedical. It received FDA 510(k) clearance on 2016-06-14 under 510(k) number K160238. 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 Airborne Phototherapy Light?

Airborne Phototherapy Light is a medical device that received FDA 510(k) clearance on 2016-06-14. The listed applicant is International Biomedical. The 510(k) number is K160238.

When did Airborne Phototherapy Light receive FDA 510(k) clearance?

Airborne Phototherapy Light received FDA 510(k) clearance on 2016-06-14, under 510(k) number K160238.

Who is the listed applicant for Airborne Phototherapy Light?

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

What is the FDA product code for Airborne Phototherapy Light?

The FDA product code for Airborne Phototherapy Light is LBI.

其他以 International Biomedical 為申請人之記錄

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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

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