FDA 510(k)

蒸汽（CSPN-15）第五型集成指示器

K号: K242860 · 2025-01-17

决定日期2025-01-17

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

Type 5 Integrating Indicator for Steam (CSPN-15) is the device name listed in this FDA 510(k) record. The listed applicant is True Indicating, LLC. It received FDA 510(k) clearance on 2025-01-17 under 510(k) number K242860. 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 Type 5 Integrating Indicator for Steam (CSPN-15)?

Type 5 Integrating Indicator for Steam (CSPN-15) is a medical device that received FDA 510(k) clearance on 2025-01-17. The listed applicant is True Indicating, LLC. The 510(k) number is K242860.

When did Type 5 Integrating Indicator for Steam (CSPN-15) receive FDA 510(k) clearance?

Type 5 Integrating Indicator for Steam (CSPN-15) received FDA 510(k) clearance on 2025-01-17, under 510(k) number K242860.

Who is the listed applicant for Type 5 Integrating Indicator for Steam (CSPN-15)?

The FDA 510(k) record lists True Indicating, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Type 5 Integrating Indicator for Steam (CSPN-15)?

The FDA product code for Type 5 Integrating Indicator for Steam (CSPN-15) is JOJ.

列明True Indicating, LLC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。

K251559InstaTRU Instant Biological Indicator for Steam (IBI-05)K233413超音化学指示剂（TRO-T 和 TRO-B）K220778蒸汽化学指示剂 K210481Instant 20s Indicator K200970自含生物指示器

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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