Banyan USA 手术口罩 Level 3
K号: K211097 · 2021-09-22
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器械摘要
Banyan USA Surgical Mask Level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Banyan USA, LLC. It received FDA 510(k) clearance on 2021-09-22 under 510(k) number K211097. The device is classified under product code FXX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Banyan USA Surgical Mask Level 3?
Banyan USA Surgical Mask Level 3 is a medical device that received FDA 510(k) clearance on 2021-09-22. The listed applicant is Banyan USA, LLC. The 510(k) number is K211097.
When did Banyan USA Surgical Mask Level 3 receive FDA 510(k) clearance?
Banyan USA Surgical Mask Level 3 received FDA 510(k) clearance on 2021-09-22, under 510(k) number K211097.
Who is the listed applicant for Banyan USA Surgical Mask Level 3?
The FDA 510(k) record lists Banyan USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Banyan USA Surgical Mask Level 3?
The FDA product code for Banyan USA Surgical Mask Level 3 is FXX.
相关临床试验
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相关器械（代码：FXX）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
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