美国制造手术口罩
K号: K210101 · 2022-01-26
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器械摘要
American-Made Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is Armbrust, Inc.. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K210101. 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 American-Made Surgical Mask?
American-Made Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Armbrust, Inc.. The 510(k) number is K210101.
When did American-Made Surgical Mask receive FDA 510(k) clearance?
American-Made Surgical Mask received FDA 510(k) clearance on 2022-01-26, under 510(k) number K210101.
Who is the listed applicant for American-Made Surgical Mask?
The FDA 510(k) record lists Armbrust, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for American-Made Surgical Mask?
The FDA product code for American-Made Surgical Mask is FXX.
相关临床试验
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。
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。
K251967HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带；HALYARD* FLUIDSHIELD* 3 防雾程序口罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，带有 WrapAround 护目镜O&M Halyard, Inc.K252534Surgical Face Mask (耳挂式)Zhejiang Hangkang Medical Equipment Co., Ltd.K253398一次性手术口罩（非无菌）(EFX3PLBLKMSK300)Efofex, Inc.K252830一次性外科口罩（3P00B，C2900）Beatles Medical Supplies (Xiantao) Co., Ltd.K252650一次性医用口罩Makrite Industries, Inc.K243342KP防护口罩Kp Trading Co., Ltd.
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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