FDA 510(k)

실리콘 포리 캐瑟터 (단일 사용용)

K-번호: K172807 · 2018-06-04

신청자Changzhou Rongxin Medicine Minimal Invasion Technology

결정일2018-06-04

제품 코드EZL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Silicone Foley Catheter for single use is the device name listed in this FDA 510(k) record. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. It received FDA 510(k) clearance on 2018-06-04 under 510(k) number K172807. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Silicone Foley Catheter for single use?

Silicone Foley Catheter for single use is a medical device that received FDA 510(k) clearance on 2018-06-04. The listed applicant is Changzhou Rongxin Medicine Minimal Invasion Technology. The 510(k) number is K172807.

When did Silicone Foley Catheter for single use receive FDA 510(k) clearance?

Silicone Foley Catheter for single use received FDA 510(k) clearance on 2018-06-04, under 510(k) number K172807.

Who is the listed applicant for Silicone Foley Catheter for single use?

The FDA 510(k) record lists Changzhou Rongxin Medicine Minimal Invasion Technology as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silicone Foley Catheter for single use?

The FDA product code for Silicone Foley Catheter for single use is EZL.

공식 출처

FDA 데이터베이스에서 보기 →

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

실리콘 포리 캐瑟터 (단일 사용용)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: EZL)

공식 출처