FDA 510(k)

NovaLine SP-C35 超聲波傳感器保護器（956007）

K 號：K240164 · 2024-06-28

申請人Bain Medical Equipment (Guangzhou) Co., Ltd.

決定日期2024-06-28

產品代碼FIB

諮詢委員會GU

決定相當於

器材摘要

NovaLine SP-C35 Transducer Protector (956007) is the device name listed in this FDA 510(k) record. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2024-06-28 under 510(k) number K240164. The device is classified under product code FIB. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the NovaLine SP-C35 Transducer Protector (956007)?

NovaLine SP-C35 Transducer Protector (956007) is a medical device that received FDA 510(k) clearance on 2024-06-28. The listed applicant is Bain Medical Equipment (Guangzhou) Co., Ltd.. The 510(k) number is K240164.

When did NovaLine SP-C35 Transducer Protector (956007) receive FDA 510(k) clearance?

NovaLine SP-C35 Transducer Protector (956007) received FDA 510(k) clearance on 2024-06-28, under 510(k) number K240164.

Who is the listed applicant for NovaLine SP-C35 Transducer Protector (956007)?

The FDA 510(k) record lists Bain Medical Equipment (Guangzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovaLine SP-C35 Transducer Protector (956007)?

The FDA product code for NovaLine SP-C35 Transducer Protector (956007) is FIB.

其他以 Bain Medical Equipment (Guangzhou) Co., Ltd. 為申請人之記錄

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器材摘要

常見問題

相關臨床試驗

其他以 Bain Medical Equipment (Guangzhou) Co., Ltd. 為申請人之記錄

官方來源