FDA 510(k)

Tyvek® 卷材，用于STERLINKTM 灭菌器，CI

K号: K212198 · 2021-10-22

决定日期2021-10-22

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

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is the device name listed in this FDA 510(k) record. The listed applicant is Plasmapp Co,., Ltd.. It received FDA 510(k) clearance on 2021-10-22 under 510(k) number K212198. 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 Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer is a medical device that received FDA 510(k) clearance on 2021-10-22. The listed applicant is Plasmapp Co,., Ltd.. The 510(k) number is K212198.

When did Tyvek(R) Roll with CI for STERLINKTM Sterilizer receive FDA 510(k) clearance?

Tyvek(R) Roll with CI for STERLINKTM Sterilizer received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212198.

Who is the listed applicant for Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

The FDA 510(k) record lists Plasmapp Co,., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer?

The FDA product code for Tyvek(R) Roll with CI for STERLINKTM Sterilizer is FRG.

列明Plasmapp Co,., Ltd.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。

K231169STERLINK plus 消毒器与STERLOAD卡式，Tyvek卷材与CI用于STERLINK消毒器，Terragene Bionova SCBI (BT96)，Terragene Bionova Reader Incubators (IC10/20FRLCD，Mini-bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K223025Tyvek卷材，适用于STERLINK灭菌器，CI认证 K223015STERLINK™ FPS-15s Plus 消毒器与STERPACK™ plus卡式 K223023Terragene Bionava SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)K220345STERLINK mini 消毒器与STERLOAD mini卡式，Tyvek卷材与CI用于STERLINK消毒器，STERLINK消毒器消毒过程指示器；Terragene Bionova SCBI (BT96)，Terragene Bionova Reader Incubators (IC10/20FRLCD，Mini-Bio)，Terragene Chemdye (CD42)，Terragene Cintape (CT40)K212200STERLINKTM FPS-15s Plus 消毒器与STERLOADTM卡式

查看所有 8 个设备 →

相关器械（代码：FRG）

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。

K261897HALYARD* ARMOR-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* HEAVY-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* STANDARD-FLEX* 消毒包裹带 ASSURE-DRY* 技术；HALYARD* H300W 消毒包裹带 ASSURE-DRY* 技术O&M Halyard, Inc.K252823Dukal 烫金纸灭菌包装Dukal, LLC K253454HALYARD* ONE-STEP* 消毒包裹；HALYARD* QUICK CHECK* 消毒包裹；HALYARD* SEQUENTIAL 消毒包裹；HALYARD* SMART-FOLD* 消毒包裹O&M Halyard, Inc.K251347灭菌袋/卷Sterivic Medical Co., Ltd.K251177自封灭菌袋和卷材Guangdong Maidi Medical Co., Ltd.K250306Chex-All Sterilization Pouches and TubesPropper Manufacturing Co., Inc.

官方来源

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