手术面罩，外科口罩
K号: K213001 · 2022-05-11
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决定日期2022-05-11
产品代码FXX
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
Procedure Mask, Surgical Mask is the device name listed in this FDA 510(k) record. The listed applicant is A Plus International, Inc.. It received FDA 510(k) clearance on 2022-05-11 under 510(k) number K213001. 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 Procedure Mask, Surgical Mask?
Procedure Mask, Surgical Mask is a medical device that received FDA 510(k) clearance on 2022-05-11. The listed applicant is A Plus International, Inc.. The 510(k) number is K213001.
When did Procedure Mask, Surgical Mask receive FDA 510(k) clearance?
Procedure Mask, Surgical Mask received FDA 510(k) clearance on 2022-05-11, under 510(k) number K213001.
Who is the listed applicant for Procedure Mask, Surgical Mask?
The FDA 510(k) record lists A Plus International, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Procedure Mask, Surgical Mask?
The FDA product code for Procedure Mask, 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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