灭菌指示胶带；EO指示胶带
K号: K241036 · 2024-12-17
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决定日期2024-12-17
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
Autoclave Indicator Tape; EO Indicator Tape is the device name listed in this FDA 510(k) record. The listed applicant is Jiangmen New Era External Use Drug Co., Ltd.. It received FDA 510(k) clearance on 2024-12-17 under 510(k) number K241036. 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 Autoclave Indicator Tape; EO Indicator Tape?
Autoclave Indicator Tape; EO Indicator Tape is a medical device that received FDA 510(k) clearance on 2024-12-17. The listed applicant is Jiangmen New Era External Use Drug Co., Ltd.. The 510(k) number is K241036.
When did Autoclave Indicator Tape; EO Indicator Tape receive FDA 510(k) clearance?
Autoclave Indicator Tape; EO Indicator Tape received FDA 510(k) clearance on 2024-12-17, under 510(k) number K241036.
Who is the listed applicant for Autoclave Indicator Tape; EO Indicator Tape?
The FDA 510(k) record lists Jiangmen New Era External Use Drug Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Autoclave Indicator Tape; EO Indicator Tape?
The FDA product code for Autoclave Indicator Tape; EO Indicator Tape is JOJ.
相关临床试验
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。
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, LLCK260181LF 蒸汽灭菌过程指示胶带Intertape Polymer GroupK251991SafeSecure 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 ResearchK251048Rapicide PA 高级消毒测试条 模型参考号 = ML02-0118STERIS CorporationK243876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。
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