FDA 510(k)

iMask 一次性外科医用口罩

K号: K201182 · 2021-02-19

决定日期2021-02-19

产品代码FXX

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决定实质等同

器械摘要

iMask Disposable Surgical Face Mask is the device name listed in this FDA 510(k) record. The listed applicant is Pac-Dent, Inc.. It received FDA 510(k) clearance on 2021-02-19 under 510(k) number K201182. 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 iMask Disposable Surgical Face Mask?

iMask Disposable Surgical Face Mask is a medical device that received FDA 510(k) clearance on 2021-02-19. The listed applicant is Pac-Dent, Inc.. The 510(k) number is K201182.

When did iMask Disposable Surgical Face Mask receive FDA 510(k) clearance?

iMask Disposable Surgical Face Mask received FDA 510(k) clearance on 2021-02-19, under 510(k) number K201182.

Who is the listed applicant for iMask Disposable Surgical Face Mask?

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

What is the FDA product code for iMask Disposable Surgical Face Mask?

The FDA product code for iMask Disposable Surgical Face Mask is FXX.

列明Pac-Dent, 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。

K202674Medidenta 高速手柄 K202920OptiComp K202831iMask儿童面罩。K210189Pac-Dent 牙托基树脂 K210412Pac-Dent 陶瓷纳米复合树脂 K210186PacBond One

查看所有 8 个设备 →

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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