FDA 510(k)Momcozy 鼻吸器 (BN007)
K号: K253629 · 2026-05-26
决定日期2026-05-26
产品代码BTA
咨询委员会SU
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决定实质等同
器械摘要
Momcozy Nasal Aspirator (BN007) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-05-26 under 510(k) number K253629. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Momcozy Nasal Aspirator (BN007)?
Momcozy Nasal Aspirator (BN007) is a medical device that received FDA 510(k) clearance on 2026-05-26. The listed applicant is Shenzhen Root Innovation Technology Co., Ltd.. The 510(k) number is K253629.
When did Momcozy Nasal Aspirator (BN007) receive FDA 510(k) clearance?
Momcozy Nasal Aspirator (BN007) received FDA 510(k) clearance on 2026-05-26, under 510(k) number K253629.
Who is the listed applicant for Momcozy Nasal Aspirator (BN007)?
The FDA 510(k) record lists Shenzhen Root Innovation Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Momcozy Nasal Aspirator (BN007)?
The FDA product code for Momcozy Nasal Aspirator (BN007) is BTA.
相关临床试验
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。
列明Shenzhen Root Innovation Technology 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。
K254254Momcozy可穿戴吸奶器（BP311, BP311-A, BP311-B, BP311-C, BP311-D）K260538Momcozy可穿戴吸奶器（BP420, BP420-A, BP420-B, BP420-C, BP420-D ）K260134Baby 鼻吸器（BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021）K253914Momcozy可穿戴吸奶器（型号：BP334, BP334-A, BP334-B, BP334-C, BP334-D, BP434）K254258Momcozy可穿戴吸奶器（BP137, BP137-A, BP137-B, BP137-C, BP137-D, BP137Y-A, BP137Y-B, BP141, BP141-A, BP141-B, BP141-C, BP141-D）K253946Momcozy可穿戴吸奶器（S9 Pro, S9 Pro-A, S9 Pro-B, S9 Pro-C, S9 Pro-D, S9 ProY-A, S9 ProY-B, S9 ProY-C, S12 Pro, S12 Pro-A, S12 Pro-B, S12 Pro-C, S12 Pro-D, S12 ProY-A, S12 ProY-B, S12 ProY-C） 查看所有 13 个设备 →
相关器械（代码：BTA）
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。
K260134Baby 鼻吸器（BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A, BN008-B, BN008-C, BN008-D, BC-021）Shenzhen Root Innovation Technology Co., Ltd.K260892吸水泵（SU-90）Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473电动鼻吸器（BC027, BC030, BC033, BC035, BC035B）Shenzhen Kingboom Technology Co., Ltd.K253107电动鼻吸器 (DT10 和 DT50, DX80, DX85, DX86 和 DX90)Shenzhen Dongjiang Technology Co., Ltd.K260147电动鼻吸器（BC026, BC025, BC023, BC028, BC029, BC036）Shenzhen Kingboom Technology Co., Ltd.K251450Baby 鼻吸器（BN002）；Baby 鼻吸器（BN006）；Baby 鼻吸器（BN007）；Baby 鼻吸器（BN008）；Baby 鼻吸器（BN009）Shenzhen Desida Technology Co., Ltd.