FDA 510(k)

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

K-번호: K203078 · 2022-08-19

신청자Huizhou Tianchang Industrial Co., Ltd.

결정일2022-08-19

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is the device name listed in this FDA 510(k) record. The listed applicant is Huizhou Tianchang Industrial Co., Ltd.. It received FDA 510(k) clearance on 2022-08-19 under 510(k) number K203078. 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 CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is a medical device that received FDA 510(k) clearance on 2022-08-19. The listed applicant is Huizhou Tianchang Industrial Co., Ltd.. The 510(k) number is K203078.

When did CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW receive FDA 510(k) clearance?

CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW received FDA 510(k) clearance on 2022-08-19, under 510(k) number K203078.

Who is the listed applicant for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

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

What is the FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW?

The FDA product code for CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW is FXX.

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CAREWE Surgical Face Mask Models N001-AW, N002-AW, and N003-AW

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FXX)

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