FDA 510(k)

Disposable Double Lumen Endobronchial Tube

Número K: K232529 · 2024-05-13

RequerenteShenzhen Insighters Medical Technology Co., Ltd.

Data da decisão2024-05-13

Código do produtoCBI

Comité consultivoAN

DecisãoSubstantially Equivalent

Resumo do dispositivo

Disposable Double Lumen Endobronchial Tube is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-05-13 under 510(k) number K232529. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Disposable Double Lumen Endobronchial Tube?

Disposable Double Lumen Endobronchial Tube is a medical device that received FDA 510(k) clearance on 2024-05-13. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. The 510(k) number is K232529.

When did Disposable Double Lumen Endobronchial Tube receive FDA 510(k) clearance?

Disposable Double Lumen Endobronchial Tube received FDA 510(k) clearance on 2024-05-13, under 510(k) number K232529.

Who is the listed applicant for Disposable Double Lumen Endobronchial Tube?

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

What is the FDA product code for Disposable Double Lumen Endobronchial Tube?

The FDA product code for Disposable Double Lumen Endobronchial Tube is CBI.

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Outros registros que listam Shenzhen Insighters Medical Technology Co., Ltd. como candidato(a)

K242793Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B12A 4.6/2.0; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B22A 5.5 /2.6; Insighters™ Single-use Bronchoscope/Insight Bimodel-Integral iS-B26A 6.0/3.0; Insighters™ Insight Workstation iS-PF1.K232580Disposable Endobronchial Blocker Tube

Dispositivos Relacionados (Código: CBI)

Fonte oficial

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