FDA 510(k)

의료용 마스크, 모델명: MY020003

K-번호: K211165 · 2021-11-09

신청자Huizhou Jie Bai Purification Co., Ltd.

결정일2021-11-09

제품 코드FXX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

Medical Face Masks, Model Name:MY020003 is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. It received FDA 510(k) clearance on 2021-11-09 under 510(k) number K211165. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Medical Face Masks, Model Name:MY020003?

Medical Face Masks, Model Name:MY020003 is a medical device that received FDA 510(k) clearance on 2021-11-09. The listed applicant is Huizhou Jie Bai Purification Co., Ltd.. The 510(k) number is K211165.

When did Medical Face Masks, Model Name:MY020003 receive FDA 510(k) clearance?

Medical Face Masks, Model Name:MY020003 received FDA 510(k) clearance on 2021-11-09, under 510(k) number K211165.

Who is the listed applicant for Medical Face Masks, Model Name:MY020003?

The FDA 510(k) record lists Huizhou Jie Bai Purification Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Masks, Model Name:MY020003?

The FDA product code for Medical Face Masks, Model Name:MY020003 is FXX.

공식 출처

FDA 데이터베이스에서 보기 →

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

의료용 마스크, 모델명: MY020003

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FXX)

공식 출처