FDA 510(k)

비아파인 토탈 크림

K-번호: K190342 · 2019-10-18

결정일2019-10-18

제품 코드FRO

결정대체적으로 동일

기기 요약

BIAFINE Topical Cream is the device name listed in this FDA 510(k) record. The listed applicant is Bausch Health Americas Incorporated. It received FDA 510(k) clearance on 2019-10-18 under 510(k) number K190342. 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 BIAFINE Topical Cream?

BIAFINE Topical Cream is a medical device that received FDA 510(k) clearance on 2019-10-18. The listed applicant is Bausch Health Americas Incorporated. The 510(k) number is K190342.

When did BIAFINE Topical Cream receive FDA 510(k) clearance?

BIAFINE Topical Cream received FDA 510(k) clearance on 2019-10-18, under 510(k) number K190342.

Who is the listed applicant for BIAFINE Topical Cream?

The FDA 510(k) record lists Bausch Health Americas Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIAFINE Topical Cream?

The FDA product code for BIAFINE Topical Cream 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.

비아파인 토탈 크림

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FRO)

공식 출처