Medical Mask
K-Number: K201729 · 2020-12-03
ApplicantZhende Medical Co., Ltd.
Decision Date2020-12-03
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Mask is a medical device manufactured by Zhende Medical Co., Ltd.. It received FDA 510(k) clearance on 2020-12-03 under approval number K201729. 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 Mask?
Medical Mask is a medical device that received FDA 510(k) clearance on 2020-12-03. It is manufactured by Zhende Medical Co., Ltd.. The 510(k) number is K201729.
When was Medical Mask approved by the FDA?
Medical Mask received FDA 510(k) clearance on 2020-12-03, under approval number K201729.
What company makes Medical Mask?
Medical Mask is manufactured by Zhende Medical Co., Ltd..
What is the FDA product code for Medical Mask?
The FDA product code for Medical Mask is FXX.
Other Devices by Zhende Medical Co., Ltd.
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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.