FDA 510(k)

Hi bebe super (Models BT-150S and BT-150L)

K号: K200675 · 2021-02-10

决定日期2021-02-10

产品代码HGX

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决定实质等同

器械摘要

Hi bebe super (Models BT-150S and BT-150L) 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 2021-02-10 under 510(k) number K200675. 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 (Models BT-150S and BT-150L)?

Hi bebe super (Models BT-150S and BT-150L) is a medical device that received FDA 510(k) clearance on 2021-02-10. The listed applicant is Bistos Co., Ltd.. The 510(k) number is K200675.

When did Hi bebe super (Models BT-150S and BT-150L) receive FDA 510(k) clearance?

Hi bebe super (Models BT-150S and BT-150L) received FDA 510(k) clearance on 2021-02-10, under 510(k) number K200675.

Who is the listed applicant for Hi bebe super (Models BT-150S and BT-150L)?

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 (Models BT-150S and BT-150L)?

The FDA product code for Hi bebe super (Models BT-150S and BT-150L) 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。

K251512Hi bebe super (BT-150B)K232991BT-1000 K210289婴儿光疗设备 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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