一次性医用口罩
K号: K201974 · 2021-03-07
广告
决定日期2021-03-07
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
Single-use medical face mask is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. It received FDA 510(k) clearance on 2021-03-07 under 510(k) number K201974. 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 Single-use medical face mask?
Single-use medical face mask is a medical device that received FDA 510(k) clearance on 2021-03-07. The listed applicant is Guangdong Horigen Mother & Baby Products Co., Ltd.. The 510(k) number is K201974.
When did Single-use medical face mask receive FDA 510(k) clearance?
Single-use medical face mask received FDA 510(k) clearance on 2021-03-07, under 510(k) number K201974.
Who is the listed applicant for Single-use medical face mask?
FDA 510(k)记录将广东好基因母婴用品有限公司列为申请人。这本身并不能确立该设备制造商的身份。
What is the FDA product code for Single-use medical face mask?
The FDA product code for Single-use medical face 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。
列明Guangdong Horigen Mother & Baby Products Co., Ltd.为申报人的其他记录
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。
广告