FDA 510(k)

SteriTite 容器系统与 MediTray 零件

K号: K221492 · 2022-10-07

决定日期2022-10-07

产品代码KCT

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

SteriTite Container System with MediTray Parts is the device name listed in this FDA 510(k) record. The listed applicant is Case Medical, Inc.. It received FDA 510(k) clearance on 2022-10-07 under 510(k) number K221492. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SteriTite Container System with MediTray Parts?

SteriTite Container System with MediTray Parts is a medical device that received FDA 510(k) clearance on 2022-10-07. The listed applicant is Case Medical, Inc.. The 510(k) number is K221492.

When did SteriTite Container System with MediTray Parts receive FDA 510(k) clearance?

SteriTite Container System with MediTray Parts received FDA 510(k) clearance on 2022-10-07, under 510(k) number K221492.

Who is the listed applicant for SteriTite Container System with MediTray Parts?

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

What is the FDA product code for SteriTite Container System with MediTray Parts?

The FDA product code for SteriTite Container System with MediTray Parts is KCT.

列明Case Medical, 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。

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官方来源

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