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FDA 510(k)

Disposable Medical Face Mask

K-Number: K202676 · 2021-11-05

ApplicantZhejiang Senhong Medical&Instrument Co., Ltd.
Decision Date2021-11-05
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Disposable Medical Face Mask is a medical device manufactured by Zhejiang Senhong Medical&Instrument Co., Ltd.. It received FDA 510(k) clearance on 2021-11-05 under approval number K202676. 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 Disposable Medical Face Mask?

Disposable Medical Face Mask is a medical device that received FDA 510(k) clearance on 2021-11-05. It is manufactured by Zhejiang Senhong Medical&Instrument Co., Ltd.. The 510(k) number is K202676.

When was Disposable Medical Face Mask approved by the FDA?

Disposable Medical Face Mask received FDA 510(k) clearance on 2021-11-05, under approval number K202676.

What company makes Disposable Medical Face Mask?

Disposable Medical Face Mask is manufactured by Zhejiang Senhong Medical&Instrument Co., Ltd..

What is the FDA product code for Disposable Medical Face Mask?

The FDA product code for Disposable Medical Face Mask is FXX.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

Related Devices (Code: FXX)

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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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