FDA 510(k)

比利-胡特

K 號：K190899 · 2019-09-05

決定日期2019-09-05

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

bili-hut is the device name listed in this FDA 510(k) record. The listed applicant is Little Sparrows Technologies, Inc.. It received FDA 510(k) clearance on 2019-09-05 under 510(k) number K190899. 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 bili-hut?

bili-hut is a medical device that received FDA 510(k) clearance on 2019-09-05. The listed applicant is Little Sparrows Technologies, Inc.. The 510(k) number is K190899.

When did bili-hut receive FDA 510(k) clearance?

bili-hut received FDA 510(k) clearance on 2019-09-05, under 510(k) number K190899.

Who is the listed applicant for bili-hut?

The FDA 510(k) record lists Little Sparrows Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for bili-hut?

The FDA product code for bili-hut is LBI.

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 K182178neoBLUE 紅外線光療系統Natus Medical Incorporated K172656BiliLuxDraeger Medical Systems, Inc.

官方來源

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