FDA 510(k)

FORA NAS100 電子鼻吸器，電子鼻吸器

K 號：K180863 · 2018-12-19

決定日期2018-12-19

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

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator is the device name listed in this FDA 510(k) record. The listed applicant is Taidoc Technology Corporation. It received FDA 510(k) clearance on 2018-12-19 under 510(k) number K180863. 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 FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Taidoc Technology Corporation. The 510(k) number is K180863.

When did FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator receive FDA 510(k) clearance?

FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator received FDA 510(k) clearance on 2018-12-19, under 510(k) number K180863.

Who is the listed applicant for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

The FDA 510(k) record lists Taidoc Technology Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator?

The FDA product code for FORA NAS100 Electronic Nasal Aspirator, Electronic Nasal Aspirator is BTA.

其他以 Taidoc Technology Corporation 為申請人之記錄

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。

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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.K253107電動鼻吸器（DT10及DT50，DX80，DX85，DX86及DX90）Shenzhen Dongjiang Technology Co., Ltd.K260147電動鼻吸器（BC026、BC025、BC023、BC028、BC029、BC036）Shenzhen Kingboom Technology Co., Ltd.

官方來源

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