FDA 510(k)

气体-Chex 指示器

K号: K212592 · 2022-01-20

决定日期2022-01-20

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

Gas-Chex Indicator is the device name listed in this FDA 510(k) record. The listed applicant is Propper Manufacturing Co., Inc.. It received FDA 510(k) clearance on 2022-01-20 under 510(k) number K212592. 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 Gas-Chex Indicator?

Gas-Chex Indicator is a medical device that received FDA 510(k) clearance on 2022-01-20. The listed applicant is Propper Manufacturing Co., Inc.. The 510(k) number is K212592.

When did Gas-Chex Indicator receive FDA 510(k) clearance?

Gas-Chex Indicator received FDA 510(k) clearance on 2022-01-20, under 510(k) number K212592.

Who is the listed applicant for Gas-Chex Indicator?

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

What is the FDA product code for Gas-Chex Indicator?

The FDA product code for Gas-Chex Indicator is JOJ.

列明Propper Manufacturing Co., Inc.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。

K250306Chex-All Sterilization Pouches and Tubes K240910EO Chex 指示胶带 K222137OK Plus 指示器 K210866Steri-Dot Process Indicator K210553蒸汽-Dot 处理指示器

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

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。