FDA 510(k)

엔도루미크 플루오레스센스 가이드드 간장 캘리브레이션 튜브 (FG 보우지)

K-번호: K222880 · 2023-03-03

결정일2023-03-03

제품 코드KNT

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is the device name listed in this FDA 510(k) record. The listed applicant is Endolumik, Inc.. It received FDA 510(k) clearance on 2023-03-03 under 510(k) number K222880. The device is classified under product code KNT. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is a medical device that received FDA 510(k) clearance on 2023-03-03. The listed applicant is Endolumik, Inc.. The 510(k) number is K222880.

When did Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) receive FDA 510(k) clearance?

Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) received FDA 510(k) clearance on 2023-03-03, under 510(k) number K222880.

Who is the listed applicant for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

The FDA 510(k) record lists Endolumik, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie)?

The FDA product code for Endolumik Fluorescence Guided Gastric Calibration Tube (FG Bougie) is KNT.

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FDA 데이터베이스에서 보기 →

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

엔도루미크 플루오레스센스 가이드드 간장 캘리브레이션 튜브 (FG 보우지)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: KNT)

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