FDA 510(k)

Hi bebe super (BT-150B)

K号: K251512 · 2025-09-25

决定日期2025-09-25

产品代码HGX

咨询委员会OB 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

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.

常见问题

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.

列明Bistos Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232991BT-1000 K210289婴儿光疗设备 K200675Hi bebe super (Models BT-150S and BT-150L)K160274Hi bebe plus

相关器械（代码：HGX）

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K254203可穿戴式乳腺泵（型号S36）Shenzhen TPH Technology Co., Ltd.K261622飞利浦新安怡自然护理免手提电动吸奶器（型号：SCF593/52，SCF593/62）；飞利浦新安怡自然护理加热免手提电动吸奶器（型号：SCF594/52，SCF594/62）Philips Consumer Lifestyle B.V.K262774可穿戴式乳腺泵（型号：XN/MD-2249BS，ZFHF）Guangdong Horigen Mother & Baby Products Co., Ltd.K260643Cimilre 双重最大Cimilre Co., Ltd.K261298可穿戴电动吸奶器（YM-8837，YM-8838，YM-8856(H03)，YM-8809(S42)）Guangdong Youmeng Electrical Technology Co., Ltd.K260259DiscreetDuo™ 流动式穿戴型乳房吸奶器（型号 S3）Shenzhen TPH Technology Co., Ltd.

官方来源

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