FDA 510(k)

AMSure baloon inflation with sterile water를 위한 프리-필드 주사기

K-번호: K181814 · 2018-09-04

결정일2018-09-04

제품 코드EZL

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is the device name listed in this FDA 510(k) record. The listed applicant is Amsino International, Inc.. It received FDA 510(k) clearance on 2018-09-04 under 510(k) number K181814. 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 AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is a medical device that received FDA 510(k) clearance on 2018-09-04. The listed applicant is Amsino International, Inc.. The 510(k) number is K181814.

When did AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water receive FDA 510(k) clearance?

AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water received FDA 510(k) clearance on 2018-09-04, under 510(k) number K181814.

Who is the listed applicant for AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

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

What is the FDA product code for AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water?

The FDA product code for AMSure Pre-filled Syringe for Balloon Inflation with Sterile Water is EZL.

Amsino International, Inc.를 신청인으로 등재한 기타 기록

K252543AMSafe 관리 세트 (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)K220230AMSure 엔터알 페이드 팩스 K220267AMSafe 뉴플로 니들리스 커넥터 K213522AMSafe 프리-필드 정상 나트륨 염수 주사기 K200051푸글 PUGGLE 엔터럴 푸징 펌프 및 푸징 세트 K183473AMSafe(R) 프리-필드 정상 나트륨 염수 주사기

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