FDA 510(k)

鼻吸器（BC-021、BC-022、BC-023、BC-024、BC-025、BC-026）

K 號：K242028 · 2024-11-19

申請人Dongguanshi Yiyingmei Technology Co., Ltd.

決定日期2024-11-19

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

Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguanshi Yiyingmei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-19 under 510(k) number K242028. 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 Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)?

Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) is a medical device that received FDA 510(k) clearance on 2024-11-19. The listed applicant is Dongguanshi Yiyingmei Technology Co., Ltd.. The 510(k) number is K242028.

When did Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) receive FDA 510(k) clearance?

Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) received FDA 510(k) clearance on 2024-11-19, under 510(k) number K242028.

Who is the listed applicant for Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)?

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

What is the FDA product code for Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026)?

The FDA product code for Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026) is BTA.

其他以 Dongguanshi Yiyingmei Technology Co., Ltd. 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。

K231969BASEN 穿著式乳泵（型號：YM-801, YM-803, YM-805, YM-806, YM-808）

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。

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官方來源

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