FDA 510(k)

gi-4000 Electrosurgical Generator

K-번호: K192265 · 2020-05-21

결정일2020-05-21

제품 코드GEI

자문 위원회SU

결정Substantially Equivalent

기기 요약

gi-4000 Electrosurgical Generator is the device name listed in this FDA 510(k) record. The listed applicant is United States Endoscopy Group, Inc.. It received FDA 510(k) clearance on 2020-05-21 under 510(k) number K192265. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the gi-4000 Electrosurgical Generator?

gi-4000 Electrosurgical Generator is a medical device that received FDA 510(k) clearance on 2020-05-21. The listed applicant is United States Endoscopy Group, Inc.. The 510(k) number is K192265.

When did gi-4000 Electrosurgical Generator receive FDA 510(k) clearance?

gi-4000 Electrosurgical Generator received FDA 510(k) clearance on 2020-05-21, under 510(k) number K192265.

Who is the listed applicant for gi-4000 Electrosurgical Generator?

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

What is the FDA product code for gi-4000 Electrosurgical Generator?

The FDA product code for gi-4000 Electrosurgical Generator is GEI.

United States Endoscopy Group, Inc.를 신청인으로 등재한 기타 기록

K200745Lariat, Hot/Cold Snare K192059Bio Guard Air/Water & Suction Valves K191559AquaShield 시스템 CO2, AquaShield 시스템 CO2-PENTAX, AquaShield 시스템 CO2-FUJIFILM K182909Roth Net Retriever Product Line K182258AquaShield 시스템 CO2 ; AquaShield 시스템 CO2 - PENTAX ; AquaShield 시스템 CO2 - Fujifilm K173650AquaShield 시스템 CO2- Fujifilm

10개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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