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FDA 510(k)

Durio外科口罩，型号501（三层，蓝色）和545（四层，蓝色）

K号: K230395 · 2023-07-17

申请人Durio Ppe Sdn Bhd
决定日期2023-07-17
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

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is the device name listed in this FDA 510(k) record. The listed applicant is Durio Ppe Sdn Bhd. It received FDA 510(k) clearance on 2023-07-17 under 510(k) number K230395. 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 Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) is a medical device that received FDA 510(k) clearance on 2023-07-17. The listed applicant is Durio Ppe Sdn Bhd. The 510(k) number is K230395.

When did Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) receive FDA 510(k) clearance?

Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) received FDA 510(k) clearance on 2023-07-17, under 510(k) number K230395.

Who is the listed applicant for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

The FDA 510(k) record lists Durio Ppe Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue)?

The FDA product code for Durio Surgical Face Mask, Models 501 (3-ply, blue) and 545 (4-ply,blue) 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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

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

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