FDA 510(k)

Disposable Double Lumen Endobronchial Tube

N.º K: K232529 · 2024-05-13

SolicitanteShenzhen Insighters Medical Technology Co., Ltd.

Fecha de decisión2024-05-13

Código de productoCBI

Comité asesorAN

DecisiónSubstantially Equivalent

Resumen del 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.

Preguntas frecuentes

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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Otros registros que enlistan a Shenzhen Insighters Medical Technology Co., Ltd. como solicitante

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)

Fuente oficial

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