FDA 510(k)

超音化学指示剂（TRO-T 和 TRO-B）

K号: K233413 · 2024-06-26

决定日期2024-06-26

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

Ultraphon Chemical Indicator (TRO-T and TRO-B) 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 2024-06-26 under 510(k) number K233413. 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 Ultraphon Chemical Indicator (TRO-T and TRO-B)?

Ultraphon Chemical Indicator (TRO-T and TRO-B) is a medical device that received FDA 510(k) clearance on 2024-06-26. The listed applicant is True Indicating, LLC. The 510(k) number is K233413.

When did Ultraphon Chemical Indicator (TRO-T and TRO-B) receive FDA 510(k) clearance?

Ultraphon Chemical Indicator (TRO-T and TRO-B) received FDA 510(k) clearance on 2024-06-26, under 510(k) number K233413.

Who is the listed applicant for Ultraphon Chemical Indicator (TRO-T and TRO-B)?

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 Ultraphon Chemical Indicator (TRO-T and TRO-B)?

The FDA product code for Ultraphon Chemical Indicator (TRO-T and TRO-B) 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。

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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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