FDA 510(k)

STERLINKTM FPS-15s Plus 消毒器与STERLOADTM卡式

K号: K212200 · 2021-10-22

决定日期2021-10-22

产品代码MLR

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

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette 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 K212200. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette 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 K212200.

When did STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette receive FDA 510(k) clearance?

STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette received FDA 510(k) clearance on 2021-10-22, under 510(k) number K212200.

Who is the listed applicant for STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

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 STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette?

The FDA product code for STERLINKTM FPS-15s Plus Sterilizer with STERLOADTM Cassette is MLR.

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)K212193Terragene Bionova SCBI (BT96), Terragene Bionova Reader Incubators (IC10/20FRLCD, Mini-bio), Terragene Chemdye (CD42), Terragene Cintape (CT40)

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官方来源

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