FDA 510(k)

PRIMUS Healthcare灭菌器（型号PSS11-HC）

K号: K221474 · 2023-02-10

决定日期2023-02-10

产品代码FLE

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

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is the device name listed in this FDA 510(k) record. The listed applicant is Primus Sterilizer Company, LLC. It received FDA 510(k) clearance on 2023-02-10 under 510(k) number K221474. The device is classified under product code FLE. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) is a medical device that received FDA 510(k) clearance on 2023-02-10. The listed applicant is Primus Sterilizer Company, LLC. The 510(k) number is K221474.

When did PRIMUS Healthcare Sterilizer (Model PSS11-HC) receive FDA 510(k) clearance?

PRIMUS Healthcare Sterilizer (Model PSS11-HC) received FDA 510(k) clearance on 2023-02-10, under 510(k) number K221474.

Who is the listed applicant for PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

The FDA 510(k) record lists Primus Sterilizer Company, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HC)?

The FDA product code for PRIMUS Healthcare Sterilizer (Model PSS11-HC) is FLE.

列明Primus Sterilizer Company, LLC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。

K233132PRIMUS Healthcare灭菌器（型号PSS11-HA & PSS11-HB）

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。