FDA 510(k)

OMF ASP System

K号: K220648 · 2022-08-11

决定日期2022-08-11

产品代码DZJ

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决定实质等同

器械摘要

OMF ASP System is the device name listed in this FDA 510(k) record. The listed applicant is Vha Dean. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K220648. The device is classified under product code DZJ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the OMF ASP System?

OMF ASP System is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is Vha Dean. The 510(k) number is K220648.

When did OMF ASP System receive FDA 510(k) clearance?

OMF ASP System received FDA 510(k) clearance on 2022-08-11, under 510(k) number K220648.

Who is the listed applicant for OMF ASP System?

The FDA 510(k) record lists Vha Dean as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OMF ASP System?

The FDA product code for OMF ASP System is DZJ.

列明Vha Dean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。

K222639VHA 放疗冲剂

官方来源

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