FDA 510(k)

验证蒸汽集成指示器，验证蒸汽集成指示器 5CM

K号: K213412 · 2022-01-21

决定日期2022-01-21

产品代码JOJ

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

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM is the device name listed in this FDA 510(k) record. The listed applicant is Steris Corparation. It received FDA 510(k) clearance on 2022-01-21 under 510(k) number K213412. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM?

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM is a medical device that received FDA 510(k) clearance on 2022-01-21. The listed applicant is Steris Corparation. The 510(k) number is K213412.

When did VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM receive FDA 510(k) clearance?

VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM received FDA 510(k) clearance on 2022-01-21, under 510(k) number K213412.

Who is the listed applicant for VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM?

The FDA 510(k) record lists Steris Corparation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM?

The FDA product code for VERIFY STEAM Integrating Indicator, VERIFY STEAM Integrating Indicator 5CM is JOJ.

列明Steris Corparation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。

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相关器械（代码：JOJ）

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。

K2619923M™ Attest™ 蒸汽化学集成器（1243A、1243B、1243RE、1243RES）Solventum US, LLC K260181LF 蒸汽灭菌过程指示胶带Intertape Polymer Group K251991SafeSecure 蒸汽灭菌过程指示器（4012，4013，4014，4016）；SafeSecure 氢氧化过氧化物蒸汽灭菌过程指示器（4211，4212，4213）Shenzhen Safesecure Medical Infection Control Tech Co. , Ltd.K251035DISINTEK™ PA 测试条Serim Research K251048Rapicide PA 高级消毒测试条模型参考号 = ML02-0118STERIS Corporation K243876验证蒸汽集成指示器STERIS Corporation

官方来源

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