FDA 510(k)

Anexa Wound Flush, 스타일리zed Water & 스타일리zed Normal Saline

K-번호: K161658 · 2016-09-14

결정일2016-09-14

제품 코드FRO

결정대체적으로 동일

기기 요약

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is the device name listed in this FDA 510(k) record. The listed applicant is Anexa Biomedical, Inc.. It received FDA 510(k) clearance on 2016-09-14 under 510(k) number K161658. 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 Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline is a medical device that received FDA 510(k) clearance on 2016-09-14. The listed applicant is Anexa Biomedical, Inc.. The 510(k) number is K161658.

When did Anexa Wound Flush, Sterile Water & Sterile Normal Saline receive FDA 510(k) clearance?

Anexa Wound Flush, Sterile Water & Sterile Normal Saline received FDA 510(k) clearance on 2016-09-14, under 510(k) number K161658.

Who is the listed applicant for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

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

What is the FDA product code for Anexa Wound Flush, Sterile Water & Sterile Normal Saline?

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

Anexa Biomedical, Inc.를 신청인으로 등재한 기타 기록

K172486Anexa Wound Flush, USP 스타일리zed 물, 그리고 USP 스타일리zed 정상 나트륨塩수 (0.9% 나트륨塩) 120 mL 컵, USP 스타일리zed 물, 그리고 USP 스타일리zed 정상 나트륨塩수 (0.9% 나트륨塩) 100mL 병, USP 스타일리zed 물, 그리고 USP 스타일리zed 정상 나트륨塩수 (0.9% 나트륨塩) 250mL 병, USP 스타일리zed 물, 그리고 USP 스타일리zed 정상 나트륨塩수 (0.9% 나트륨塩) 500mL 병

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