FDA 510(k)

Disposable Endobronchial Blocker Tube

K-번호: K232580 · 2023-12-14

신청자Shenzhen Insighters Medical Technology Co., Ltd.

결정일2023-12-14

제품 코드CBI

자문 위원회AN

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Shenzhen Insighters Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

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

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.