Child Face Mask
K-Number: K201514 · 2021-10-10
Decision Date2021-10-10
Product CodeOXZ
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Child Face Mask is a medical device manufactured by Shandong Shengquan New Material Co., Ltd.. It received FDA 510(k) clearance on 2021-10-10 under approval number K201514. The device is classified under product code OXZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Child Face Mask?
Child Face Mask is a medical device that received FDA 510(k) clearance on 2021-10-10. It is manufactured by Shandong Shengquan New Material Co., Ltd.. The 510(k) number is K201514.
When was Child Face Mask approved by the FDA?
Child Face Mask received FDA 510(k) clearance on 2021-10-10, under approval number K201514.
What company makes Child Face Mask?
Child Face Mask is manufactured by Shandong Shengquan New Material Co., Ltd..
What is the FDA product code for Child Face Mask?
The FDA product code for Child Face Mask is OXZ.
Other Devices by Shandong Shengquan New Material 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.