FDA 510(k)

AMSure 스타일리드 워터, 그리고 상처 씻기용 정상 나트륨 염수

K-번호: K181423 · 2018-09-07

결정일2018-09-07

제품 코드FRO

결정대체적으로 동일

기기 요약

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush 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 2018-09-07 under 510(k) number K181423. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is a medical device that received FDA 510(k) clearance on 2018-09-07. The listed applicant is Amsino International, Inc.. The 510(k) number is K181423.

When did AMSure Sterile Water, and Sterile Normal Saline for Wound Flush receive FDA 510(k) clearance?

AMSure Sterile Water, and Sterile Normal Saline for Wound Flush received FDA 510(k) clearance on 2018-09-07, under 510(k) number K181423.

Who is the listed applicant for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush?

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 Sterile Water, and Sterile Normal Saline for Wound Flush?

The FDA product code for AMSure Sterile Water, and Sterile Normal Saline for Wound Flush is FRO. This falls under the Anesthesiology category.

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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