FDA 510(k)

NovaLine SP-C35 Transducer Protector (956007)

Número K: K240164 · 2024-06-28

RequerenteBain Medical Equipment (Guangzhou) Co., Ltd.

Data da decisão2024-06-28

Código do produtoFIB

Comité consultivoGU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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