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FDA 510(k)

电动鼻吸器 (DT10 和 DT50, DX80, DX85, DX86 和 DX90)

K号: K253107 · 2026-04-14

申请人Shenzhen Dongjiang Technology Co., Ltd.
决定日期2026-04-14
产品代码BTA
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决定实质等同

器械摘要

Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Dongjiang Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-04-14 under 510(k) number K253107. 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 Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)?

Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) is a medical device that received FDA 510(k) clearance on 2026-04-14. The listed applicant is Shenzhen Dongjiang Technology Co., Ltd.. The 510(k) number is K253107.

When did Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) receive FDA 510(k) clearance?

Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) received FDA 510(k) clearance on 2026-04-14, under 510(k) number K253107.

Who is the listed applicant for Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)?

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

What is the FDA product code for Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)?

The FDA product code for Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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。

K253629Momcozy 鼻吸器 (BN007)Shenzhen Root Innovation Technology Co., Ltd.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.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.

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。

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