FDA 510(k)

엘메드 라파로스코픽 도구 및 액세서리

K-번호: K181173 · 2019-03-22

결정일2019-03-22

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

ELMED Laparoscopic Instruments and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Elmed Incorporated. It received FDA 510(k) clearance on 2019-03-22 under 510(k) number K181173. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ELMED Laparoscopic Instruments and Accessories?

ELMED Laparoscopic Instruments and Accessories is a medical device that received FDA 510(k) clearance on 2019-03-22. The listed applicant is Elmed Incorporated. The 510(k) number is K181173.

When did ELMED Laparoscopic Instruments and Accessories receive FDA 510(k) clearance?

ELMED Laparoscopic Instruments and Accessories received FDA 510(k) clearance on 2019-03-22, under 510(k) number K181173.

Who is the listed applicant for ELMED Laparoscopic Instruments and Accessories?

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

What is the FDA product code for ELMED Laparoscopic Instruments and Accessories?

The FDA product code for ELMED Laparoscopic Instruments and Accessories is GCJ.

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엘메드 라파로스코픽 도구 및 액세서리

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GCJ)

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