FDA 510(k)

PureWay 1.4 Quart Sharps Collector

K号: K231484 · 2023-09-14

决定日期2023-09-14

产品代码MMK

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

PureWay 1.4 Quart Sharps Collector is the device name listed in this FDA 510(k) record. The listed applicant is Pureway Compliance, Inc.. It received FDA 510(k) clearance on 2023-09-14 under 510(k) number K231484. The device is classified under product code MMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PureWay 1.4 Quart Sharps Collector?

PureWay 1.4 Quart Sharps Collector is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is Pureway Compliance, Inc.. The 510(k) number is K231484.

When did PureWay 1.4 Quart Sharps Collector receive FDA 510(k) clearance?

PureWay 1.4 Quart Sharps Collector received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231484.

Who is the listed applicant for PureWay 1.4 Quart Sharps Collector?

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

What is the FDA product code for PureWay 1.4 Quart Sharps Collector?

The FDA product code for PureWay 1.4 Quart Sharps Collector is MMK.

列明Pureway Compliance, 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。

K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)

相关器械（代码：MMK）

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。

官方来源

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