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FDA 510(k)

Medical Face Mask

K-Number: K214087 · 2022-03-08

Decision Date2022-03-08
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Medical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Hubei Medlink Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2022-03-08 under 510(k) number K214087. 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?

Medical Face Mask is a medical device that received FDA 510(k) clearance on 2022-03-08. The listed applicant is Hubei Medlink Healthcare Co., Ltd.. The 510(k) number is K214087.

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

Medical Face Mask received FDA 510(k) clearance on 2022-03-08, under 510(k) number K214087.

Who is the listed applicant for Medical Face Mask?

The FDA 510(k) record lists Hubei Medlink Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medical Face Mask?

The FDA product code for Medical Face Mask is FXX.

Other records listing Hubei Medlink Healthcare 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.

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.

Official Source

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