FDA 510(k)

FerriSmart 分析系统

K号: K182218 · 2018-11-30

申请人Resonance Health Analysis Services Pty, Ltd.

决定日期2018-11-30

产品代码PCS

咨询委员会RA

决定实质等同

器械摘要

FerriSmart Analysis System is the device name listed in this FDA 510(k) record. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. It received FDA 510(k) clearance on 2018-11-30 under 510(k) number K182218. The device is classified under product code PCS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the FerriSmart Analysis System?

FerriSmart Analysis System is a medical device that received FDA 510(k) clearance on 2018-11-30. The listed applicant is Resonance Health Analysis Services Pty, Ltd.. The 510(k) number is K182218.

When did FerriSmart Analysis System receive FDA 510(k) clearance?

FerriSmart Analysis System received FDA 510(k) clearance on 2018-11-30, under 510(k) number K182218.

Who is the listed applicant for FerriSmart Analysis System?

The FDA 510(k) record lists Resonance Health Analysis Services Pty, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FerriSmart Analysis System?

The FDA product code for FerriSmart Analysis System is PCS.

列明Resonance Health Analysis Services Pty, Ltd.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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官方来源

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