FDA 510(k)

3 Layer 수술 마스크 (134252531)

K-번호: K231618 · 2023-07-28

결정일2023-07-28

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

3 Layer Surgical Mask (134252531) is the device name listed in this FDA 510(k) record. The listed applicant is Original Mattress Factory, Inc.. It received FDA 510(k) clearance on 2023-07-28 under 510(k) number K231618. 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 3 Layer Surgical Mask (134252531)?

3 Layer Surgical Mask (134252531) is a medical device that received FDA 510(k) clearance on 2023-07-28. The listed applicant is Original Mattress Factory, Inc.. The 510(k) number is K231618.

When did 3 Layer Surgical Mask (134252531) receive FDA 510(k) clearance?

3 Layer Surgical Mask (134252531) received FDA 510(k) clearance on 2023-07-28, under 510(k) number K231618.

Who is the listed applicant for 3 Layer Surgical Mask (134252531)?

The FDA 510(k) record lists Original Mattress Factory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3 Layer Surgical Mask (134252531)?

The FDA product code for 3 Layer Surgical Mask (134252531) is FXX.

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3 Layer 수술 마스크 (134252531)

기기 요약

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관련 임상시험

관련 기기 (코드: FXX)

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