Medical Face Mask
K-Number: K213736 · 2022-03-31
ApplicantHangzhou Runheng Medical Co., Ltd.
Decision Date2022-03-31
Product CodeFXX
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Medical Face Mask is a medical device manufactured by Hangzhou Runheng Medical Co., Ltd.. It received FDA 510(k) clearance on 2022-03-31 under approval number K213736. 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 2022-03-31. It is manufactured by Hangzhou Runheng Medical Co., Ltd.. The 510(k) number is K213736.
When was Medical Face Mask approved by the FDA?
Medical Face Mask received FDA 510(k) clearance on 2022-03-31, under approval number K213736.
What company makes Medical Face Mask?
Medical Face Mask is manufactured by Hangzhou Runheng Medical Co., Ltd..
What is the FDA product code for Medical Face Mask?
The FDA product code for Medical Face Mask is FXX.
Other Devices by Hangzhou Runheng 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.