FDA 510(k)

2D Quantitative Analysis

K号: K161839 · 2016-07-29

申请人Philips Medical Systems Nederland B.V.

决定日期2016-07-29

产品代码OWB

咨询委员会RA

决定Substantially Equivalent

器械摘要

2D Quantitative Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medical Systems Nederland B.V.. It received FDA 510(k) clearance on 2016-07-29 under 510(k) number K161839. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the 2D Quantitative Analysis?

2D Quantitative Analysis is a medical device that received FDA 510(k) clearance on 2016-07-29. The listed applicant is Philips Medical Systems Nederland B.V.. The 510(k) number is K161839.

When did 2D Quantitative Analysis receive FDA 510(k) clearance?

2D Quantitative Analysis received FDA 510(k) clearance on 2016-07-29, under 510(k) number K161839.

Who is the listed applicant for 2D Quantitative Analysis?

The FDA 510(k) record lists Philips Medical Systems Nederland B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 2D Quantitative Analysis?

The FDA product code for 2D Quantitative Analysis is OWB.

列明Philips Medical Systems Nederland B.V.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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