FDA 510(k)

Disposable Surgical Face Mask (FM-34EE,FM-44EE)

K-번호: K220597 · 2022-05-26

신청자Qingdao Bestex Rubber & Plastic Products Co., Ltd.

결정일2022-05-26

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

Disposable Surgical Face Mask (FM-34EE,FM-44EE) is the device name listed in this FDA 510(k) record. The listed applicant is Qingdao Bestex Rubber & Plastic Products Co., Ltd.. It received FDA 510(k) clearance on 2022-05-26 under 510(k) number K220597. 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 Disposable Surgical Face Mask (FM-34EE,FM-44EE)?

Disposable Surgical Face Mask (FM-34EE,FM-44EE) is a medical device that received FDA 510(k) clearance on 2022-05-26. The listed applicant is Qingdao Bestex Rubber & Plastic Products Co., Ltd.. The 510(k) number is K220597.

When did Disposable Surgical Face Mask (FM-34EE,FM-44EE) receive FDA 510(k) clearance?

Disposable Surgical Face Mask (FM-34EE,FM-44EE) received FDA 510(k) clearance on 2022-05-26, under 510(k) number K220597.

Who is the listed applicant for Disposable Surgical Face Mask (FM-34EE,FM-44EE)?

The FDA 510(k) record lists Qingdao Bestex Rubber & Plastic Products Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Disposable Surgical Face Mask (FM-34EE,FM-44EE)?

The FDA product code for Disposable Surgical Face Mask (FM-34EE,FM-44EE) is FXX.

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Disposable Surgical Face Mask (FM-34EE,FM-44EE)

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관련 임상시험

관련 기기 (코드: FXX)

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