SteroScope® 灭菌技术系统
K号: K233762 · 2024-06-27
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决定日期2024-06-27
产品代码MLR
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
SteroScope® Sterilization Technology System is the device name listed in this FDA 510(k) record. The listed applicant is Ideate Medical, Inc.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233762. The device is classified under product code MLR. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the SteroScope® Sterilization Technology System?
SteroScope® Sterilization Technology System is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Ideate Medical, Inc.. The 510(k) number is K233762.
When did SteroScope® Sterilization Technology System receive FDA 510(k) clearance?
SteroScope® Sterilization Technology System received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233762.
Who is the listed applicant for SteroScope® Sterilization Technology System?
The FDA 510(k) record lists Ideate Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for SteroScope® Sterilization Technology System?
The FDA product code for SteroScope® Sterilization Technology System is MLR.
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：MLR）
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。
K252843STERRAD 100NX 消毒系统，配备 ALLClear 技术（10104）Advanced Sterilization Products, Inc.K250802STERRAD® 100NX 消毒器，配备 ALLClear® 技术（10104）Advanced Sterilization Products, Inc.K231893LOWTEM Crystal 120Lowtem Co., Ltd.K234082STERRAD® 100NX 消毒器，配备 ALLClear® 技术和 ULTRA GI® 循环（10104）；APTIMAX® 仪器托盘，用于 ULTRA GI® 循环（011077）Advanced Sterilization ProductsK233065V-PRO maX 2 低温灭菌系统SterisK223476V-PRO maX 2 低温灭菌系统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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