BAYLAB 3 层手术口罩（BEACON I）
K号: K212302 · 2021-12-07
广告
器械摘要
BAYLAB 3-Ply Surgical Mask (BEACON I) is the device name listed in this FDA 510(k) record. The listed applicant is Baylab USA, LLC. It received FDA 510(k) clearance on 2021-12-07 under 510(k) number K212302. 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 BAYLAB 3-Ply Surgical Mask (BEACON I)?
BAYLAB 3-Ply Surgical Mask (BEACON I) is a medical device that received FDA 510(k) clearance on 2021-12-07. The listed applicant is Baylab USA, LLC. The 510(k) number is K212302.
When did BAYLAB 3-Ply Surgical Mask (BEACON I) receive FDA 510(k) clearance?
BAYLAB 3-Ply Surgical Mask (BEACON I) received FDA 510(k) clearance on 2021-12-07, under 510(k) number K212302.
Who is the listed applicant for BAYLAB 3-Ply Surgical Mask (BEACON I)?
The FDA 510(k) record lists Baylab USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for BAYLAB 3-Ply Surgical Mask (BEACON I)?
The FDA product code for BAYLAB 3-Ply Surgical Mask (BEACON I) 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。
广告