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FDA 510(k)

Medical Face Mask (M001)

K-Number: K221273 · 2022-06-28

ApplicantXingyu Medical Tech Co., Ltd.
Decision Date2022-06-28
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Face Mask (M001) is the device name listed in this FDA 510(k) record. The listed applicant is Xingyu Medical Tech Co., Ltd.. It received FDA 510(k) clearance on 2022-06-28 under 510(k) number K221273. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Face Mask (M001)?

Medical Face Mask (M001) is a medical device that received FDA 510(k) clearance on 2022-06-28. The listed applicant is Xingyu Medical Tech Co., Ltd.. The 510(k) number is K221273.

When did Medical Face Mask (M001) receive FDA 510(k) clearance?

Medical Face Mask (M001) received FDA 510(k) clearance on 2022-06-28, under 510(k) number K221273.

Who is the listed applicant for Medical Face Mask (M001)?

The FDA 510(k) record lists Xingyu Medical Tech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Mask (M001)?

The FDA product code for Medical Face Mask (M001) is FXX.

Other records listing Xingyu Medical Tech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FXX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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