FDA 510(k)

嗨貝貝超級（BT-150B）

K 號：K251512 · 2025-09-25

決定日期2025-09-25

產品代碼HGX

諮詢委員會OB設備之醫療設備規範文本翻譯如下：關於OB設備的醫療設備規範文件：此設備已通過FDA認證，並獲得510(k)許可證。該設備的PMA申請已提交，並在NCT登錄編號為[編號]的研究中進行測試。相關文獻的PMID編號為[編號]。請參考以下識別碼和網址：識別碼：[識別碼] 網址：[網址] 政策：醫療規範-v1

決定相當於

器材摘要

Hi bebe super (BT-150B) is the device name listed in this FDA 510(k) record. The listed applicant is Bistos Co., Ltd.. It received FDA 510(k) clearance on 2025-09-25 under 510(k) number K251512. The device is classified under product code HGX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Hi bebe super (BT-150B)?

Hi bebe super (BT-150B) is a medical device that received FDA 510(k) clearance on 2025-09-25. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K251512.

When did Hi bebe super (BT-150B) receive FDA 510(k) clearance?

Hi bebe super (BT-150B) received FDA 510(k) clearance on 2025-09-25, under 510(k) number K251512.

Who is the listed applicant for Hi bebe super (BT-150B)?

The FDA 510(k) record lists Bistos Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hi bebe super (BT-150B)?

The FDA product code for Hi bebe super (BT-150B) is HGX.

其他以 Bistos Co., Ltd. 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。

K232991BT-1000 K210289嬰兒光療設備 K200675嗨貝貝超級（型號 BT-150S 和 BT-150L）K160274嗨，貝貝加

相關器械（代碼：HGX）

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。

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官方來源

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