FDA 510(k)

Disposable Endobronchial Blocker Tube

K-Nummer: K232580 · 2023-12-14

AntragstellerShenzhen Insighters Medical Technology Co., Ltd.

Entscheidungsdatum2023-12-14

ProduktcodeCBI

BeratungsausschussAN

EntscheidungSubstantially Equivalent

Produktübersicht

Disposable Endobronchial Blocker 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 2023-12-14 under 510(k) number K232580. The device is classified under product code CBI. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Disposable Endobronchial Blocker Tube?

Disposable Endobronchial Blocker Tube is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Shenzhen Insighters Medical Technology Co., Ltd.. The 510(k) number is K232580.

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

Disposable Endobronchial Blocker Tube received FDA 510(k) clearance on 2023-12-14, under 510(k) number K232580.

Who is the listed applicant for Disposable Endobronchial Blocker 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 Endobronchial Blocker Tube?

The FDA product code for Disposable Endobronchial Blocker Tube is CBI.

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Weitere Einträge mit Shenzhen Insighters Medical Technology Co., Ltd. als Antragsteller

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.K232529Disposable Double Lumen Endobronchial Tube

Verwandte Geräte (Code: CBI)

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