FDA 510(k)

Procellera Composite Antibacterial Wound Dressing

K-번호: K180533 · 2018-12-10

결정일2018-12-10

제품 코드FRO

결정Substantially Equivalent

기기 요약

Procellera Composite Antibacterial Wound Dressing is the device name listed in this FDA 510(k) record. The listed applicant is Vomaris Wound Care, Inc.. It received FDA 510(k) clearance on 2018-12-10 under 510(k) number K180533. 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 Procellera Composite Antibacterial Wound Dressing?

Procellera Composite Antibacterial Wound Dressing is a medical device that received FDA 510(k) clearance on 2018-12-10. The listed applicant is Vomaris Wound Care, Inc.. The 510(k) number is K180533.

When did Procellera Composite Antibacterial Wound Dressing receive FDA 510(k) clearance?

Procellera Composite Antibacterial Wound Dressing received FDA 510(k) clearance on 2018-12-10, under 510(k) number K180533.

Who is the listed applicant for Procellera Composite Antibacterial Wound Dressing?

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

What is the FDA product code for Procellera Composite Antibacterial Wound Dressing?

The FDA product code for Procellera Composite Antibacterial Wound Dressing is FRO. This falls under the Anesthesiology category.

공식 출처

FDA 데이터베이스에서 보기 →

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

Procellera Composite Antibacterial Wound Dressing

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FRO)

공식 출처