FDA 510(k)

PMW01 手术口罩级别 1

K号: K211772 · 2021-12-06

决定日期2021-12-06

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

PMW01 Procedure Mask Level 1 is the device name listed in this FDA 510(k) record. The listed applicant is Defender Safety, Inc.. It received FDA 510(k) clearance on 2021-12-06 under 510(k) number K211772. 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 PMW01 Procedure Mask Level 1?

PMW01 Procedure Mask Level 1 is a medical device that received FDA 510(k) clearance on 2021-12-06. The listed applicant is Defender Safety, Inc.. The 510(k) number is K211772.

When did PMW01 Procedure Mask Level 1 receive FDA 510(k) clearance?

PMW01 Procedure Mask Level 1 received FDA 510(k) clearance on 2021-12-06, under 510(k) number K211772.

Who is the listed applicant for PMW01 Procedure Mask Level 1?

The FDA 510(k) record lists Defender Safety, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PMW01 Procedure Mask Level 1?

The FDA product code for PMW01 Procedure Mask Level 1 is FXX.

列明Defender Safety, Inc.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。

K210705Defender 安全程序口罩 Level 1, Defender 安全程序口罩 Level 3, Defender 安全外科口罩 Level 3

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。