FDA 510(k)

HALYARD ONE-STEP 消毒包裹，HALYARD QUICK CHECK 消毒包裹

K号: K214007 · 2022-07-27

决定日期2022-07-27

产品代码FRG

咨询委员会医疗设备监管文本翻译如下： HO 请注意，由于您没有提供具体的医疗设备监管文本内容，以上仅为示例。请提供具体的文本内容以便进行准确的翻译。

决定实质等同

器械摘要

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is the device name listed in this FDA 510(k) record. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. It received FDA 510(k) clearance on 2022-07-27 under 510(k) number K214007. The device is classified under product code FRG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is a medical device that received FDA 510(k) clearance on 2022-07-27. The listed applicant is Owens & Minor (O&M) Halyard, Inc.. The 510(k) number is K214007.

When did HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap receive FDA 510(k) clearance?

HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap received FDA 510(k) clearance on 2022-07-27, under 510(k) number K214007.

Who is the listed applicant for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?

The FDA 510(k) record lists Owens & Minor (O&M) Halyard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap?

The FDA product code for HALYARD ONE-STEP Sterilization Wrap, HALYARD QUICK CHECK Sterilization Wrap is FRG.

列明Owens & Minor (O&M) Halyard, 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。

K243010Fluidshield * 3 防雾手术口罩带环绕防眩视窗（28804）；Fluidshield * 3 手术口罩带 SO SOFT* 内衬（48208）；Fluidshield * 3 防雾手术口罩带 SO SOFT* 内衬（48207）；Fluidshield * 3 防雾手术口罩带 SO SOFT* 内衬，带视窗（48237）；Fluidshield* 3 防雾手术口罩带 SO SOFT* 内衬，防眩环绕视窗（48247）；Fluidshield * 3 防雾手术程序口罩带 SO SOFT* 耳带（28797）；Fluidshield * 3 防雾程序 K232824FLUIDSHIELD* 1 无雾手术面罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，白色（41802）；FLUIDSHIELD* 1 无雾手术面罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，白色，环绕式护目镜（41803）；FLUIDSHIELD* 1 手术面罩，带有 SO SOFT* 内衬，白色，（41805）K232777FLUIDSHIELD* 1 手术面罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，淡紫色（25868）；FLUIDSHIELD* 1 无雾手术面罩，带有 SO SOFT* 内衬和 SO SOFT* 耳带，淡紫色，环绕式护目镜（41798）K232807Fluidshield* 1 程序口罩带 SO SOFT* 内衬和 SO SOFT 耳带（25869）；Fluidshield* 1 手术口罩带 SO SOFT* 内衬（28802）K232812Fluidshield* 2 防雾手术口罩（62113）；Fluidshield* 2 防雾手术口罩带环绕视窗（62114）；Fluidshield* 2 程序口罩带 SO SOFT* 耳带（62115）；Fluidshield* 2 程序口罩带 SO SOFT* 耳带和环绕视窗（62116）K232806HALYARD* FLUIDSHIELD* 1 手术口罩，带有 So Soft Lining 和 So Soft 耳带（25867）；HALYARD* Level 1 手术口罩（48388）

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官方来源

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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。