FDA 510(k)

Celesteion，PCA-9000A/3

K号: K170490 · 2017-06-01

决定日期2017-06-01

产品代码KPS

咨询委员会RA

决定实质等同

器械摘要

Celesteion, PCA-9000A/3 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-01 under 510(k) number K170490. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Celesteion, PCA-9000A/3?

Celesteion, PCA-9000A/3 is a medical device that received FDA 510(k) clearance on 2017-06-01. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170490.

When did Celesteion, PCA-9000A/3 receive FDA 510(k) clearance?

Celesteion, PCA-9000A/3 received FDA 510(k) clearance on 2017-06-01, under 510(k) number K170490.

Who is the listed applicant for Celesteion, PCA-9000A/3?

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

What is the FDA product code for Celesteion, PCA-9000A/3?

The FDA product code for Celesteion, PCA-9000A/3 is KPS.

列明Toshibamedical Systems Corporation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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相关器械（代码：KPS）

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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