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FDA 510(k)

Comfort Guard Mask, 级别 1, Comfort Guard Mask, 级别 3

K号: K210860 · 2022-04-07

申请人Gri-Alleset, Inc.
决定日期2022-04-07
产品代码FXX
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决定实质等同

器械摘要

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is the device name listed in this FDA 510(k) record. The listed applicant is Gri-Alleset, Inc.. It received FDA 510(k) clearance on 2022-04-07 under 510(k) number K210860. 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 Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 is a medical device that received FDA 510(k) clearance on 2022-04-07. The listed applicant is Gri-Alleset, Inc.. The 510(k) number is K210860.

When did Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 receive FDA 510(k) clearance?

Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 received FDA 510(k) clearance on 2022-04-07, under 510(k) number K210860.

Who is the listed applicant for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

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

What is the FDA product code for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3?

The FDA product code for Comfort Guard Mask, level 1, Comfort Guard Mask, level 3 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

列明Gri-Alleset, 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。

K242664gentleheel®成人切口设备K220917gentleheel 微小早产儿，gentleheel 早产儿，gentleheel 新生儿，gentleheel 婴儿K210131ComfortGuard 手术隔离服

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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