FDA 510(k)

Plasma IQ

K号: K192813 · 2020-03-06

决定日期2020-03-06

产品代码GEI

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决定实质等同

器械摘要

Plasma IQ is the device name listed in this FDA 510(k) record. The listed applicant is Neauvia North America, Inc.. It received FDA 510(k) clearance on 2020-03-06 under 510(k) number K192813. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Plasma IQ?

Plasma IQ is a medical device that received FDA 510(k) clearance on 2020-03-06. The listed applicant is Neauvia North America, Inc.. The 510(k) number is K192813.

When did Plasma IQ receive FDA 510(k) clearance?

Plasma IQ received FDA 510(k) clearance on 2020-03-06, under 510(k) number K192813.

Who is the listed applicant for Plasma IQ?

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

What is the FDA product code for Plasma IQ?

The FDA product code for Plasma IQ is GEI.

列明Neauvia North America, 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。

K223222Plasma IQ K212329Plasma IQ

相关器械（代码：GEI）

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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