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FDA 510(k)

電動鼻吸器（DT10及DT50，DX80，DX85，DX86及DX90）

K 號：K253107 · 2026-04-14

申請人Shenzhen Dongjiang Technology Co., Ltd.
決定日期2026-04-14
產品代碼BTA
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

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.

常見問題

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.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：BTA）

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。

K253629Momcozy 鼻吸器 (BN007)Shenzhen Root Innovation Technology Co., Ltd.K260134嬰兒鼻吸器（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吸引泵（SU-90）Shenzhen HugeMed Medical Technical Development Co., Ltd.K260473電動鼻吸器（BC027、BC030、BC033、BC035、BC035B）Shenzhen Kingboom Technology Co., Ltd.K260147電動鼻吸器（BC026、BC025、BC023、BC028、BC029、BC036）Shenzhen Kingboom Technology Co., Ltd.K251450嬰兒鼻吸器（BN002）；嬰兒鼻吸器（BN006）；嬰兒鼻吸器（BN007）；嬰兒鼻吸器（BN008）；嬰兒鼻吸器（BN009）Shenzhen Desida Technology Co., Ltd.

官方來源

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