FDA 510(k)

AMSafe(R) 프리-필드 정상 나트륨 염수 주사기

K-번호: K183473 · 2019-07-12

결정일2019-07-12

제품 코드NGT

자문 위원회HO

결정Substantially Equivalent

기기 요약

AMSafe(R) Pre-Filled Normal Saline Flush Syringe 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 2019-07-12 under 510(k) number K183473. The device is classified under product code NGT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe is a medical device that received FDA 510(k) clearance on 2019-07-12. The listed applicant is Amsino International, Inc.. The 510(k) number is K183473.

When did AMSafe(R) Pre-Filled Normal Saline Flush Syringe receive FDA 510(k) clearance?

AMSafe(R) Pre-Filled Normal Saline Flush Syringe received FDA 510(k) clearance on 2019-07-12, under 510(k) number K183473.

Who is the listed applicant for AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

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 AMSafe(R) Pre-Filled Normal Saline Flush Syringe?

The FDA product code for AMSafe(R) Pre-Filled Normal Saline Flush Syringe is NGT.

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 K200051PUGGLE Enteral Feeding Pump and Feeding Set K181445AMSure 히드로필릭 인터미트 캐빗터

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