FDA 510(k)

아퀼레كس 플루이드 컨트롤 시스템 AQL-100S

K-번호: K172040 · 2018-02-05

결정일2018-02-05

제품 코드HIG

자문 위원회OB

결정Substantially Equivalent

기기 요약

Aquilex Fluid Control System AQL-100S is the device name listed in this FDA 510(k) record. The listed applicant is W.O.M. World of Medicine GmbH. It received FDA 510(k) clearance on 2018-02-05 under 510(k) number K172040. The device is classified under product code HIG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aquilex Fluid Control System AQL-100S?

Aquilex Fluid Control System AQL-100S is a medical device that received FDA 510(k) clearance on 2018-02-05. The listed applicant is W.O.M. World of Medicine GmbH. The 510(k) number is K172040.

When did Aquilex Fluid Control System AQL-100S receive FDA 510(k) clearance?

Aquilex Fluid Control System AQL-100S received FDA 510(k) clearance on 2018-02-05, under 510(k) number K172040.

Who is the listed applicant for Aquilex Fluid Control System AQL-100S?

The FDA 510(k) record lists W.O.M. World of Medicine GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aquilex Fluid Control System AQL-100S?

The FDA product code for Aquilex Fluid Control System AQL-100S is HIG.

W.O.M. World of Medicine GmbH를 신청인으로 등재한 기타 기록

K250795PUREVUE™ FMS K201361PNEUMOCLEAR K173311ARTHRO-Pump PA304 K173489GYN-Pump PH304 K170784PNEUMOCLEAR K163320LAP-Pump PP110

8개 장치 모두 보기 →

공식 출처

FDA 데이터베이스에서 보기 →

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