FDA 510(k)

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

K-번호: K210772 · 2021-09-22

결정일2021-09-22

제품 코드FXX

자문 위원회SU

결정Substantially Equivalent

기기 요약

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is the device name listed in this FDA 510(k) record. The listed applicant is Vr Vertical, LLC Dba Xrgo. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K210772. 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 Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Vr Vertical, LLC Dba Xrgo. The 510(k) number is K210772.

When did 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) receive FDA 510(k) clearance?

3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) received FDA 510(k) clearance on 2021-09-22, under 510(k) number K210772.

Who is the listed applicant for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

The FDA 510(k) record lists Vr Vertical, LLC Dba Xrgo as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)?

The FDA product code for 3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT) is FXX.

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3-Layer Medical Face Masks (XMM3L3C), 3-Layer Medical Face Masks with ties (XMM3HT)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: FXX)

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